GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K-Number: K232178 · 2023-09-19
ApplicantDRGEM Corporation
Decision Date2023-09-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2023-09-19 under approval number K232178. 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-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is a medical device that received FDA 510(k) clearance on 2023-09-19. It is manufactured by DRGEM Corporation. The 510(k) number is K232178.
When was GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) approved by the FDA?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) received FDA 510(k) clearance on 2023-09-19, under approval number K232178.
What company makes GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is manufactured by DRGEM Corporation.
What is the FDA product code for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
The FDA product code for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is KPR.
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Official Source
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