Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
FDA 510(k) K203537 · Sedecal., Sa.
510(k) numberK203537
Submission
- Device name
- Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
- Applicant
- Sedecal., Sa.
Algete, ES - Received
- December 3, 2020
- Decision date
- February 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems cleared by the FDA?
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems (K203537) received a 510(k) decision of Substantially Equivalent on February 1, 2021, 60 days after the submission was received.
What is the product code of K203537?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.