FDA 510(k)

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

K-번호: K243473 · 2025-07-29

신청자Prognosys Medical Systems Private Limited

결정일2025-07-29

제품 코드IZL

자문 위원회RA

결정Substantially Equivalent

기기 요약

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K243473. 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 PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K243473.

When did PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS receive FDA 510(k) clearance?

PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS received FDA 510(k) clearance on 2025-07-29, under 510(k) number K243473.

Who is the listed applicant for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

The FDA 510(k) record lists Prognosys Medical Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS?

The FDA product code for PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS is IZL.

Prognosys Medical Systems Private Limited를 신청인으로 등재한 기타 기록

K240771PRORAD X-Ray Flat Panel Detector with DROC K183541ProRad 2FC and ProRad 3NC Stationary Radiographic Systems

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