FDA 510(k)

의료용 X선 진단 시스템

K-번호: K243411 · 2025-05-19

신청자Nanjing Perlove Medical Equipment Co., Ltd.

결정일2025-05-19

제품 코드OWB

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

결정대체적으로 동일

기기 요약

Diagnostic X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Perlove Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K243411. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Diagnostic X-ray System?

Diagnostic X-ray System is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Nanjing Perlove Medical Equipment Co., Ltd.. The 510(k) number is K243411.

When did Diagnostic X-ray System receive FDA 510(k) clearance?

Diagnostic X-ray System received FDA 510(k) clearance on 2025-05-19, under 510(k) number K243411.

Who is the listed applicant for Diagnostic X-ray System?

The FDA 510(k) record lists Nanjing Perlove Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diagnostic X-ray System?

The FDA product code for Diagnostic X-ray System is OWB.

Nanjing Perlove Medical Equipment Co., Ltd.를 신청인으로 등재한 기타 기록

K212134의료용 X선 검사 시스템/PLX5200A

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