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FDA 510(k)

GXR-Series Diagnostic X-Ray System

K-Number: K202572 · 2020-09-24

Decision Date2020-09-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GXR-Series Diagnostic X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2020-09-24 under 510(k) number K202572. 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 GXR-Series Diagnostic X-Ray System?

GXR-Series Diagnostic X-Ray System is a medical device that received FDA 510(k) clearance on 2020-09-24. The listed applicant is DRGEM Corporation. The 510(k) number is K202572.

When did GXR-Series Diagnostic X-Ray System receive FDA 510(k) clearance?

GXR-Series Diagnostic X-Ray System received FDA 510(k) clearance on 2020-09-24, under 510(k) number K202572.

Who is the listed applicant for GXR-Series Diagnostic X-Ray System?

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

What is the FDA product code for GXR-Series Diagnostic X-Ray System?

The FDA product code for GXR-Series Diagnostic X-Ray System is KPR.

Other records listing DRGEM Corporation 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 13 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.