SonoSite
- About Sonosite
- Product Line
- M-Turbo™
M-Turbo™
Ideal for broader applications, this versatile powerhouse with brilliant image quality can help you perform anything from abdominal to vascular, to cardiac exams with speed and accuracy.
- S Series™
S Series™
For situations where you need a streamlined device with fewer buttons, bells and whistles, amazingly clear image quality and a fast, easy way to transport patient data.
- M-OB/GYN Office™
M-OB/GYN Office
More specialized ultrasound = more focused medicine. We engineered the M-OB/GYN office ultrasound tool to be just what you need in a point-of-care system.
- MicroMaxx®
MicroMaxx®
A laptop-sized, durable unit representing the technology crossover point between hand-carried ultrasound and larger, high-performance, cart-based systems.
- More Products
More Products
SonoSite software and previous generations.
- Trade In, Trade Up
- M-Turbo™
- Resources
- globe
The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.
Regulatory Compliance
Regulatory & Compliance / Documentation / Formats
The data contained within the Technical Data Files (TDF) for SonoSite devices, and provided for inclusion in marketing authorization applications covers all the requirements of the regulatory authorities. The TDF format is provided below.
1 Basic Information
1.1 Manufacturer's Name & Address
1.2 Authorized Representative In The European Union
1.3 Competent Authority
1.4 Notified Body
2 Declarations of Conformity
3 Purpose and Scope
8 Device Summary
9 Changes
10 Device Classification, Intended Use, And Indications For Use
10.1 Device Classification
10.2 Patient Population
10.3 Environment
10.4 Transducer, Exam Type, and Imaging Mode
10.5 Indications for Use and Intended Uses
10.6 Indications For Use
11 General Description
11.1 System Diagram and Description
11.2 Description of Operating Modes
11.3 Additional System Feature Performances
11.4 Transducer Operation in Each Mode and Mode Combination
11.4.1 Operating Controls That Affect Radiated Field\
11.4.2 Summary Information of Transducers Cleared for Use with System
11.4.3 Accessories and Kits
12 Planned Variants
13 Applicable Harmonized Standards
14 Applicable Non-Harmonized Standards
15 Design Specifications
15.1 Requirements
15.2 Plans
15.3 Specifications
15.3.1 System
15.3.2 Transducers
15.3.3 Labeling
16 Design Output
16.1 Drawings
16.2 Bills of Material
17 Essential Requirements Checklist
18 Risk Analysis
19 Product Development Procedure
20 Design Verification and Validation
20.1 Document/Design Reviews
20.2 Phase Reviews
20.3 Verification Plans, Protocols and Reports
20.4 Verification Plans, Protocols and Reports - User Guides
20.5 Validation Plans, Protocols and Reports - Human Factors
20.6 Validation Plans, Protocols and Reports - Clinical data
20.7 Regulatory Submissions & Approvals
21 Materials & Biocompatibility
22 Medicinal Product Statement
23 Manufacturing Process
24 Sterilization Certification
25 Labeling
25.1 Photographs of New and Updated Products
25.2 Labeling Layouts for Complete System
25.3 User Guides