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 / US & 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.
Links are provided below to:
- US FDA 510(k) database where copies of 510(k) substantial equivalence decisions along with SonoSite summaries of safety and effectiveness.
- Health Canada Medical Devices Active License Listing database for each product listed.
| Product | FDA 510(k) | Canada License |
| Product
Name: SonoSite high-resolution ultrasound system (C3 Series) Trade Names: MicroMaxx® high-resolution ultrasound system |
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, L25 |
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) |
Last Update: May 8, 2007