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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) 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. The listed applicant is Sedecal., Sa.. The 510(k) number is K203537.

When did Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems receive FDA 510(k) clearance?

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203537.

Who is the listed applicant for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Sedecal., Sa. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 11 devices →

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.