ExactVu High Resolution Micro-Ultrasound System
FDA 510(k) K162972 · Exact Imaging
510(k) numberK162972
Submission
- Device name
- ExactVu High Resolution Micro-Ultrasound System
- Applicant
- Exact Imaging
Markham, CA - Received
- October 25, 2016
- Decision date
- December 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was ExactVu High Resolution Micro-Ultrasound System cleared by the FDA?
ExactVu High Resolution Micro-Ultrasound System (K162972) received a 510(k) decision of Substantially Equivalent on December 2, 2016, 38 days after the submission was received.
What is the product code of K162972?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.