Harmonic Imaging with Contrast
FDA 510(k) K973767 · Acuson Corp.
510(k) numberK973767
Submission
- Device name
- Harmonic Imaging with Contrast
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- October 2, 1997
- Decision date
- December 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Harmonic Imaging with Contrast cleared by the FDA?
Harmonic Imaging with Contrast (K973767) received a 510(k) decision of Substantially Equivalent on December 23, 1997, 82 days after the submission was received.
What is the product code of K973767?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.