FDA 510(k)

럭스 HD 디터کت러, DRX-LC 디터کت러, DRX-혁신 모바일 X선 시스템

K-번호: K253185 · 2026-03-11

결정일2026-03-11

제품 코드IZL

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

결정대체적으로 동일

기기 요약

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K253185. 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 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Carestream Health. The 510(k) number is K253185.

When did Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System receive FDA 510(k) clearance?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System received FDA 510(k) clearance on 2026-03-11, under 510(k) number K253185.

Who is the listed applicant for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

The FDA 510(k) record lists Carestream Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

The FDA product code for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is IZL.

Carestream Health를 신청인으로 등재한 기타 기록

K250954DRX-Evolution Plus X-선 시스템, DRX-Compass 이동형 X-선 시스템, Lux HD 35探测器, Lux HD 43探测器 K213568DRX-Rise 모바일 X선 시스템 K203159럭스 35探测器 K163157스마트그리드

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