Fischer Pps/Mammotest Mammography System
FDA 510(k) K861692 · Fischer Imaging Corp.
510(k) numberK861692
Submission
- Device name
- Fischer Pps/Mammotest Mammography System
- Applicant
- Fischer Imaging Corp.
Elk Grove Village, IL, US - Received
- May 2, 1986
- Decision date
- December 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Fischer Pps/Mammotest Mammography System cleared by the FDA?
Fischer Pps/Mammotest Mammography System (K861692) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 227 days after the submission was received.
What is the product code of K861692?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.