FDA 510(k)

디지털 레이디오그래피 시스템 (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)

K-번호: K240284 · 2024-03-28

결정일2024-03-28

제품 코드IZL

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K240284. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Shenzhen Browiner Tech Co., Ltd.. The 510(k) number is K240284.

When did Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) receive FDA 510(k) clearance?

Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) received FDA 510(k) clearance on 2024-03-28, under 510(k) number K240284.

Who is the listed applicant for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA 510(k) record lists Shenzhen Browiner Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)?

The FDA product code for Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is IZL.

Shenzhen Browiner Tech Co., Ltd.를 신청인으로 등재한 기타 기록

K240841디지털 레이디오그래피 시스템 (ManntiX B, ManntiX K)

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.