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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-04-24 under 510(k) 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. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170858.

When did FDR AQRO (DR-XD 1000) receive FDA 510(k) clearance?

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

Who is the listed applicant for FDR AQRO (DR-XD 1000)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Fujifilm Medical Systems U.S.A, Inc. as applicant

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Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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