Athena-Hf Mammographic X-Ray System
FDA 510(k) K900989 · Fischer Imaging Corp.
510(k) numberK900989
Submission
- Device name
- Athena-Hf Mammographic X-Ray System
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- March 2, 1990
- Decision date
- March 28, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Athena-Hf Mammographic X-Ray System cleared by the FDA?
Athena-Hf Mammographic X-Ray System (K900989) received a 510(k) decision of Substantially Equivalent on March 28, 1990, 26 days after the submission was received.
What is the product code of K900989?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.