GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K-Number: K232178 · 2023-09-19
Device Summary
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. The listed applicant is DRGEM Corporation. The 510(k) number is K232178.
When did GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) receive FDA 510(k) clearance?
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) received FDA 510(k) clearance on 2023-09-19, under 510(k) number K232178.
Who is the listed applicant for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)?
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-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.
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.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.