Adc Compact (Agfa Diagnostic Center)
FDA 510(k) K974597 · Bayer Corp., Agfa Div.
510(k) numberK974597
Submission
- Device name
- Adc Compact (Agfa Diagnostic Center)
- Applicant
- Bayer Corp., Agfa Div.
Ridgefield Park, NJ, US - Received
- December 9, 1997
- Decision date
- March 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Adc Compact (Agfa Diagnostic Center) cleared by the FDA?
Adc Compact (Agfa Diagnostic Center) (K974597) received a 510(k) decision of Substantially Equivalent on March 9, 1998, 90 days after the submission was received.
What is the product code of K974597?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.