Regulatory and Compliance

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Quality Assurance


SonoSite’s quality vision is simple:
Our job is to anticipate and meet our customers’ requirements through continuous
improvement in every aspect of our business practices.
  • The quality assurance management system that supports the design, development, manufacture, testing and release of SonoSite products is comprehensive, robust and meets the requirements of both regulatory agencies and customers.
  • SonoSite products are designed and manufactured in accordance with established United States FDAi quality system regulations (21 CFR 820) and other international quality system standards including ISOi 13485:2003 and ISO 9001-2000.
  • SonoSite product designs are verified and validated and meet design input requirements and specifications, intended uses, and user needs.
  • The materials used to manufacture SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).
  • Delivered SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).

Harmonized Standards
European harmonized standards that each SonoSite-marked product complies with are listed below.
 
Reference No. Title
980 Graphical symbols for use in the labeling of medical devices (2008)
1041 Information supplied by the manufacturer with medical devices (2008)
ISO 13485 Medical devices / Quality management systems / Requirements for regulatory purposes (2003)
ISO 14971 Medical devices / Application of risk management to medical devices (2007) (ISO 14971:2007) (Superseded standard: EN 1441)
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1 series)
60601-1 A1-A2 Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991/A2:1995 + corrigendum June 1995
60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems (IEC 60601-1-4 Ed. 1.1 b:2000)
ISO 11135 series Sterilization of Health Care Products (Ethylene Oxide)
ISO 11137 series Sterilization of Health Care Products (Radiation)
60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18 Ed. 3.0 b:2009)
60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22 Ed. 3.0 b:2007)
60601-2-25 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25 Ed. 1.0 b:1993)
60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27 Ed. 2.0 b:2005)
60601-1-1 Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (2001) (IEC 601-1-1:2001)
60601-1-2 Medical electrical equipment / Part 1: General requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests (2001) (IEC 60601-1-2:2001)
60601-2-37 Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001) (IEC 60601-2-37:2001)
US/Canada European Union All Other Countries Safety/EMC

SonoSite is comprised of an innovative team of professionals with many years of experience in medical diagnostic ultrasound technology. SonoSite is at the forefront of defining a world-class standard of quality management for ultrasound manufacturing. SonoSite, Inc. is an FDA registered firm as a specification developer and manufacturer of medical devices.

SonoSite products are designed, manufactured, and distributed in full accordance with the requirements of FDA’s Quality System Regulation. We are regularly inspected by BSI - the British Standards Institute, which is SonoSite’s European “notified body” under the medical device directive. Regulatory documents for both individual devices and SonoSite’s quality management system are available.

United States/Canada

The 510(k) pre-market notification process is the most common method used in the United States for describing the design and manufacture of medical devices which the US Food and Drug Administration (FDA) uses to determine a "substantial equivalence" decision to authorize marketing of a medical device within the United States.

The Canadian regulatory process for determining safety and effectiveness of medical devices is managed by Health Canada’s Therapeutic Products Directorate.

Mercury-Added Product Information
Please see the following document which is provided in accordance with the notification requirements for mercury-added product enacted by the states of Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont.
Product FDA 510K Canada License
Product Name:
SonoSite Edge Ultrasound System
Trade Names:
SonoSite Edge™ Ultrasound System		 K113156 Addition to license pending
Product Name:
SonoSite BioZ Dx Diagnostics System
Trade Names:
SonoSite BioZ™ Dx Diagnostics System 		 K041294
K051228
K070156 		 74360 (System)   
Product Name:
SonoSite BioZ Rx Diagnostics System
Trade Names:
SonoSite BioZ™ Rx Diagnostics System 		 K090602  Pending
Product Name:
SonoSite NanoMaxx Ultrasound System
Trade Names:
SonoSite NanoMaxx™ Ultrasound System 		 K092058 12407 (System)
35918 (Transducers)
Product Name:
SonoSite M-Turbo Series Ultrasound System
Trade Names:
SonoSite M-Turbo® Ultrasound System
high-resolution ultrasound system
SonoSite M-MSK™ Ultrasound System
SonoSite M-OB/GYN Office™ Ultrasound System
 		 K071134 12407 (System)
35918 (Transducers)
36312 (ECG Cable)
61741 (Mobile Docking Station)
Product Name:
SonoSite high-resolution ultrasound system (C3 Series)
Trade Names:
MicroMaxx® high-resolution ultrasound syste		 K043559
K053069		 12407 (System)
35918 (Transducers)
36312 (ECG Cable)
61741 (Mobile Docking Station)
Product Name:
SonoSite high-resolution ultrasound system (C2 Series)
Trade Names:
TITAN® high-resolution ultrasound system		 K030949
K033367
K043452		 12407 (System)
35918 (Transducers)
36312 (ECG Cable)
61741 (Mobile Docking Station)
61742 (Needle Guide)
61743 (L25 Bracket Kit)
Product Name:
SonoSite ultrasound system (Power Series)
Trade Names:
SonoSite® iLook Personal Imaging Tool, C15
SonoSite® iLook Personal Imaging Tool, L2		 K021628
K030064
K033367		 12407 (System)
35918 (Transducers)
61742 (Needle Guide)
61743 (L25 Bracket Kit)
Product Name:
SonoSite hand-carried ultrasound system
Trade Names:
SonoSite® 180PLUS
SonoHeart® ELITE		 K014116
K010374
K033367
K043452
K052109		 12407 (System)
35918 (Transducers)
35945 (SiteStand)
36312 (ECG Cable)
61742 (Needle Guide)
61743 (L25 Bracket Kit)

European Union

To place a medical device on the market within the European Union, CE marking of the device is required and the manufacturer must comply with European Union Medical Device Directive (MDD) - Council Directive 93/42/EEC of 14 June 1993 concerning medical products as amended by 2007/47/EC. SonoSite maintains technical documentation files (TDF) on each device covered by CE marking. The TDF is made available to the notified body or national authorities for Conformity Assessments according to MDD 93/42/EEC Annex II, MDD 93/42/EEC Annex V or MDD 93/42/EEC Annex IX.

For each SonoSite device marketed within the European Union SonoSite prepares a declaration of conformity with the MDD and applies CE marking. For other countries, outside of the European Union, additional documentation is available.

The links below provide copies of declarations of conformity for each product listed.

Product Name:
SonoSite Edge Ultrasound System

Trade Names:
SonoSite Edge™ Ultrasound System

Declaration of Conformity

Product Name:
SonoSite BioZ Rx Diagnostics System

Trade Names:
SonoSite BioZ® Rx Diagnostics System

Declaration of Conformity

Product Name:
SonoSite NanoMaxx Ultrasound System

Trade Names:
SonoSite NanoMaxx™ Ultrasound System

Declaration of Conformity:

Product Name:
SonoSite M-Turbo Series Ultrasound System

Trade Names:
SonoSite M-Turbo® Ultrasound System
SonoSite M-MSK™ Ultrasound System
SonoSite M-OB/GYN Office™ Ultrasound System

Declaration of Conformity:

Product Name:
SonoSite S Series Ultrasound System

Trade Names:
SonoSite S-Nerve™ Ultrasound System
SonoSite S-FAST™ Ultrasound System
SonoSite S-ICU™ Ultrasound System
SonoSite S-Cath™ Ultrasound System
SonoSite S-MSK™ Ultrasound System
SonoSite S-GYN™ Ultrasound System
SonoSite S-VetMed™ Ultrasound System
SonoSite S-Women’s Health™ Ultrasound System

Declaration of Conformity:

Product Name:
SonoSite high-resolution ultrasound system (C3 Series)

Trade Names:
MicroMaxx® high-resolution ultrasound system

Declaration of Conformity:

Product Name:
SonoSite high-resolution ultrasound system (C2 Series)

Trade Names:
TITAN® high-resolution mobile ultrasound system

Declaration of Conformity:

Product Name:
SonoSite ultrasound system (Power Series)

Trade Names:
SonoSite® iLook Personal Imaging Tool, C15
SonoSite® iLook Personal Imaging Tool, L25

Declaration of Conformity:

Product Name:
SonoSite hand-carried ultrasound system

Trade Names:
SonoSite® 180PLUS
SonoHeart® ELITE

Declaration of Conformity:

Product Name:
L25 Needle Guide and Bracket Kit

Trade Names:
L25 Needle Guide and Bracket Kit

Declaration of Conformity:


All Other Countries

For marketing authorization applications to the regulatory authorities in a particular country, relevant technical details concerning SonoSite devices can be supplied upon request. This technical information is formatted in the style used within the European Union.

In addition, the US FDA provides export certificates, known as "Certificates to Foreign Government" (CFG) that certify a particular device may be marketed in, and legally exported from the United States of America and that the manufacturing plants in which the device is produced is subject to periodic inspections and that the last inspection showed that the plant appeared to be in substantial compliance with good manufacturing practice requirements.

For each product, the links below provide copies of:

FDA Certificates to Foreign Government
Australia TGA Declarations of Conformity
Should additional information be required that is not provided here, please advise your SonoSite sales representative of your requirements.

Product Name:
SonoSite Edge Ultrasound System

Trade Names:
SonoSite Edge™ Ultrasound System

FDA CFG
AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
SonoSite BioZ Rx Diagnostics System

Trade Names:
SonoSite BioZ® Rx Diagnostics System

AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
SonoSite NanoMaxx Series Ultrasound System

Trade Names:
SonoSite NanoMaxx™ Ultrasound System

AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
SonoSite M-Turbo Series Ultrasound System

Trade Names:
SonoSite M-Turbo® Ultrasound System
SonoSite M-MSK™ Ultrasound System
SonoSite M-OB/GYN Office™ Ultrasound System

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
SonoSite S Series Ultrasound System

Trade Names:
SonoSite S-Nerve™ Ultrasound System
SonoSite S-FAST™ Ultrasound System
SonoSite S-ICU™ Ultrasound System
SonoSite S-Cath™ Ultrasound System
SonoSite S-MSK™ Ultrasound System
SonoSite S-GYN™ Ultrasound System
SonoSite S-VetMed™ Ultrasound System
SonoSite S-Women’s Health™ Ultrasound System

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
SonoSite high-resolution ultrasound system (C3 Series)

Trade Names:
MicroMaxx® high-resolution ultrasound system

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY
JAPAN
Product Name:
SonoSite high-resolution ultrasound system (C2 Series)

Trade Names:
TITAN™ high-resolution mobile ultrasound system

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

JAPAN
Product Name:
SonoSite ultrasound system (Power Series)

Trade Names:
SonoSite® iLook Personal Imaging Tool, C15
SonoSite® iLook Personal Imaging Tool, L25

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

 

Product Name:
SonoSite hand-carried ultrasound system

Trade Names:
SonoSite® 180PLUS
SonoHeart™ ELITE

FDA CFG
AUSTRALIA DECLARATION OF CONFORMITY
Product Name:
L25 Needle Guide and Bracket Kit

Trade Names:
L25 Needle Guide and Bracket Kit

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

Weee Compliance

Regulatory & Compliance / WEEE Compliance in Europe
 
Under the Waste Electrical and Electronic Equipment (WEEE) Directive and
implementing regulations, when customers buy new electrical and electronic equipment from SonoSite they are entitled to:
  • Send old equipment for recycling on a one-for-one, like-for-like basis (this varies depending on the country)
  • Send the new equipment back for recycling when this ultimately becomes waste

Collection and Recycling Arrangements
Please contact the dealer directly to understand how they are meeting the
obligations.
There is no information for this selected country
Recyclers (in Europe)

As part of compliance with the WEEE Directive, Rackable Systems provides recycling information on request for all types of new equipment put on the market in Europe after August 13th 2005.

Please send an email to the address below and provide the following details for the product for which you would like to receive recycling information:

-- Model number of Rackable Systems product
-- Your company name
-- Contact name
-- Address
-- Telephone number
-- Email address

We will dispatch the recycling information to you shortly. Request recycling instructions (recycling@sonosite.com) for SonoSite electrical and electronic equipment put on the market after August 2005.

Strength,durability,reassurance
REGULATORY AFFAIRS CONTACT

Mary K. Moore
VP, Regulatory Affairs
(425) 951-1275
mary.moore@sonosite.com

Alternate Contact
Ken Hansen
Director, Regulatory Affairs and Quality Systems
(425) 951-6997
ken.hansen@sonosite.com

Regulatory Affairs General Information Requests:
regulatory@sonosite.com

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