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FDA 510(k)

Radiographic System Challenge X

K-Number: K202293 · 2020-10-07

ApplicantSedecal., Sa.
Decision Date2020-10-07
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radiographic System Challenge X is a medical device manufactured by Sedecal., Sa.. It received FDA 510(k) clearance on 2020-10-07 under approval number K202293. 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 Radiographic System Challenge X?

Radiographic System Challenge X is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Sedecal., Sa.. The 510(k) number is K202293.

When was Radiographic System Challenge X approved by the FDA?

Radiographic System Challenge X received FDA 510(k) clearance on 2020-10-07, under approval number K202293.

What company makes Radiographic System Challenge X?

Radiographic System Challenge X is manufactured by Sedecal., Sa..

What is the FDA product code for Radiographic System Challenge X?

The FDA product code for Radiographic System Challenge X is KPR.

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Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K161937CuattroDRCuattro, LLC K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.

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.

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