Hd-Ivus Ultrasound Imaging System
FDA 510(k) K122878 · Silicon Vally Medical Instruments, Inc.
510(k) numberK122878
Submission
- Device name
- Hd-Ivus Ultrasound Imaging System
- Applicant
- Silicon Vally Medical Instruments, Inc.
Fremont, CA, US - Received
- September 19, 2012
- Decision date
- January 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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Questions and answers
When was Hd-Ivus Ultrasound Imaging System cleared by the FDA?
Hd-Ivus Ultrasound Imaging System (K122878) received a 510(k) decision of Substantially Equivalent on January 11, 2013, 114 days after the submission was received.
What is the product code of K122878?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.