Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
K-Number: K203537 · 2021-02-01
ApplicantSedecal., Sa.
Decision Date2021-02-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2021-02-01 under approval number K203537. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is a medical device that received FDA 510(k) clearance on 2021-02-01. It is manufactured by Sedecal., Sa.. The 510(k) number is K203537.
When was Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems approved by the FDA?
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems received FDA 510(k) clearance on 2021-02-01, under approval number K203537.
What company makes Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is manufactured by Sedecal., Sa..
What is the FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?
The FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is KPR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.