DUS-6000 Digital Ultrasonic Diagnostic Imaging System
FDA 510(k) K172931 · Advanced Instrumentations, Inc.
510(k) numberK172931
Submission
- Device name
- DUS-6000 Digital Ultrasonic Diagnostic Imaging System
- Applicant
- Advanced Instrumentations, Inc.
Miami, FL, US - Received
- September 25, 2017
- Decision date
- December 1, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DUS-6000 Digital Ultrasonic Diagnostic Imaging System cleared by the FDA?
DUS-6000 Digital Ultrasonic Diagnostic Imaging System (K172931) received a 510(k) decision of Substantially Equivalent on December 1, 2017, 67 days after the submission was received.
What is the product code of K172931?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.