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FDA 510(k)

FDR AQRO (DR-XD 1000)

K-Number: K170858 · 2017-04-24

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-04-24
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FDR AQRO (DR-XD 1000) is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-24 under approval number K170858. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDR AQRO (DR-XD 1000)?

FDR AQRO (DR-XD 1000) is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170858.

When was FDR AQRO (DR-XD 1000) approved by the FDA?

FDR AQRO (DR-XD 1000) received FDA 510(k) clearance on 2017-04-24, under approval number K170858.

What company makes FDR AQRO (DR-XD 1000)?

FDR AQRO (DR-XD 1000) is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for FDR AQRO (DR-XD 1000)?

The FDA product code for FDR AQRO (DR-XD 1000) is IZL.

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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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