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FDA 510(k)

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems

K-Number: K183541 · 2019-01-24

ApplicantPrognosys Medical Systems Private Limited
Decision Date2019-01-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is a medical device manufactured by Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2019-01-24 under approval number K183541. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Prognosys Medical Systems Private Limited. The 510(k) number is K183541.

When was ProRad 2FC and ProRad 3NC Stationary Radiographic Systems approved by the FDA?

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

What company makes ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is manufactured by Prognosys Medical Systems Private Limited.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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