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 / 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 M Series Ultrasound SystemTrade Names:
SonoSite M-Turbo™ Ultrasound SystemFDA CFG
D06000 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
Ultrasound System (PDF)Accessories (PDF)
Transducers (PDF)
Product Name:
SonoSite S Series Ultrasound SystemTrade Names:
SonoSite S-Nerve™ Ultrasound SystemSonoSite S-FAST™ Ultrasound System
SonoSite S-ICU™ Ultrasound System
SonoSite S-Cath™ Ultrasound System
FDA CFG
D06000 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
Ultrasound System (PDF)Accessories (PDF)
Transducers (PDF)
Product Name:
SonoSite high-resolution ultrasound system (C3 Series)Trade Names:
MicroMaxx® high-resolution ultrasound systemFDA CFG
D04346 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
MicroMaxx System (PDF)MicroMaxx Accessories (PDF)
MicroMaxx Transducers (PDF)
JAPAN
MHLW APPROVAL 218ADBZI00032000 (PDF)Product Name:
SonoSite high-resolution ultrasound system (C2 Series)Trade Names:
TITAN™ high-resolution mobile ultrasound systemFDA CFG
D02556 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
Titan System (PDF)Titan Accessories (PDF)
Titan Transducers (PDF)
JAPAN
MHLW APPROVAL TITAN 21600BZG00002000 (PDF)Product Name:
SonoSite ultrasound system (Power Series)Trade Names:
SonoSite® iLook Personal Imaging Tool, C15SonoSite® iLook Personal Imaging Tool, L25
FDA CFG
D02557 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
iLook System (PDF)iLook Accessories (PDF)
JAPAN
MHLW APPROVAL 180PLUS / ELITE 21600BZG00001000 (PDF)Product Name:
SonoSite hand-carried ultrasound systemTrade Names:
SonoSite® 180PLUSSonoHeart™ ELITE
FDA CFG
D02877 (PDF)AUSTRALIA DECLARATION OF CONFORMITY
Ultrasound System (PDF)Accessories (PDF)
Transducers (PDF)
Product Name:
L25 Needle Guide and Bracket KitTrade Names:
L25 Needle Guide and Bracket KitFDA CFG
D04346 (PDF)D02557 (PDF)
D02877 (PDF)