Regulatory Documents

US/CanadaEuropean UnionAll Other CountriesSafety/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.

 

ProductFDA 510KCanada LicenseProduct Name:
SonoSite X-Porte Ultrasound System
Trade Names:
SonoSite X-Porte Ultrasound SystemK133134PendingProduct Name:
SonoSite Edge Ultrasound System
Trade Names:
SonoSite Edge® Ultrasound SystemK113156
K13345412407 (System)
35918 (Transducers)
61741 (Mobile Docking Station)Product Name:
SonoSite NanoMaxx Ultrasound System
Trade Names:
SonoSite NanoMaxx® Ultrasound System K092058
K101757
K10239012407 (System)
35918 (Transducers)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
 K071134
K082098
K101757
K13017312407 (System)
35918 (Transducers)
36312 (ECG Cable)
61741 (Mobile Docking Station)Product Name:
SonoSite S Series Ultrasound System
Trade Names:
SonoSite S Series™ Ultrasound System
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
 K071134
K082098
K101757
K13017312407 (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 systemK043559
K05306912407 (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 systemK023957
K030949
K033367
K04345212407 (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, L2K021628
K030064
K03336712407 (System)
35918 (Transducers)
61742 (Needle Guide)
61743 (L25 Bracket Kit)Product Name:
SonoSite hand-carried ultrasound system
Trade Names:
SonoSite® 180PLUS
SonoHeart® ELITEK014116
K010374
K033367
K043452
K05210912407 (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 X-Porte Ultrasound System

Trade Names:
SonoSite X-Porte Ultrasound System

Declaration of Conformity

Product Name:
SonoSite Edge Ultrasound System

Trade Names:
SonoSite Edge® Ultrasound 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 Series™ Ultrasound System
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 X-Porte Ultrasound System

Trade Names:
SonoSite X-Porte Ultrasound System

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

Product Name:
SonoSite Edge Ultrasound System

Trade Names:
SonoSite Edge® Ultrasound System

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

Product Name:
SonoSite NanoMaxx Series Ultrasound System

Trade Names:
SonoSite NanoMaxx® Ultrasound System

FDA CFG

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 Series™ Ultrasound System
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

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

Trade Names:
TITAN™ high-resolution mobile ultrasound system

FDA CFG

AUSTRALIA DECLARATION OF CONFORMITY

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