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FDA 510(k)

PowerDR

K-Number: K191504 · 2019-08-16

ApplicantRadiology Information Systems, Inc.
Decision Date2019-08-16
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PowerDR is a medical device manufactured by Radiology Information Systems, Inc.. It received FDA 510(k) clearance on 2019-08-16 under approval number K191504. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerDR?

PowerDR is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Radiology Information Systems, Inc.. The 510(k) number is K191504.

When was PowerDR approved by the FDA?

PowerDR received FDA 510(k) clearance on 2019-08-16, under approval number K191504.

What company makes PowerDR?

PowerDR is manufactured by Radiology Information Systems, Inc..

What is the FDA product code for PowerDR?

The FDA product code for PowerDR is JAA.

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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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