Mobile Athena HF
FDA 510(k) K922454 · Fischer Imaging Corp.
510(k) numberK922454
Submission
- Device name
- Mobile Athena HF
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- May 26, 1992
- Decision date
- September 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Mobile Athena HF cleared by the FDA?
Mobile Athena HF (K922454) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 108 days after the submission was received.
What is the product code of K922454?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.