FDA 510(k)

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems

K-번호: K183541 · 2019-01-24

신청자Prognosys Medical Systems Private Limited

결정일2019-01-24

제품 코드KPR

자문 위원회RA

결정Substantially Equivalent

기기 요약

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems 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 2019-01-24 under 510(k) number K183541. 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 ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K183541.

When did ProRad 2FC and ProRad 3NC Stationary Radiographic Systems receive FDA 510(k) clearance?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems received FDA 510(k) clearance on 2019-01-24, under 510(k) number K183541.

Who is the listed applicant for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

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 2FC and ProRad 3NC Stationary Radiographic Systems?

The FDA product code for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is KPR.

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