A2 Image Processing System
FDA 510(k) K802475 · Medtronic Vascular
510(k) numberK802475
Submission
- Device name
- A2 Image Processing System
- Applicant
- Medtronic Vascular
Walker, MI, US - Received
- October 9, 1980
- Decision date
- November 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was A2 Image Processing System cleared by the FDA?
A2 Image Processing System (K802475) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 48 days after the submission was received.
What is the product code of K802475?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.