FDA 510(k)

GXR-ES/ECS 진단 X선 시스템, (모델 GXR-ES 시리즈, GXR-ECS 시리즈)

K-번호: K232178 · 2023-09-19

결정일2023-09-19

제품 코드KPR

자문 위원회RA

결정Substantially Equivalent

기기 요약

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) is the device name listed in this FDA 510(k) record. The listed applicant is DRGEM Corporation. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K232178. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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.

DRGEM Corporation를 신청인으로 등재한 기타 기록

K260085RAYMO Mobile X-ray System (Model: RAYMO)K251443PROMO K242019GXR시리즈 진단 X선 시스템 K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)K202572GXR시리즈 진단 X선 시스템 K202156디아몬드-5A/6A/8A

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