Medrad Fluoroscopic Video Enhancement System
FDA 510(k) K884317 · Medrad, Inc.
510(k) numberK884317
Submission
- Device name
- Medrad Fluoroscopic Video Enhancement System
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- October 13, 1988
- Decision date
- December 20, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Medrad Fluoroscopic Video Enhancement System cleared by the FDA?
Medrad Fluoroscopic Video Enhancement System (K884317) received a 510(k) decision of Substantially Equivalent on December 20, 1988, 68 days after the submission was received.
What is the product code of K884317?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.