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FDA 510(k)

Edge Air(1417) Digital Flat Panel X-ray Detector

K-Number: K201503 · 2020-06-29

ApplicantOsko, Inc.
Decision Date2020-06-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Edge Air(1417) Digital Flat Panel X-ray Detector is a medical device manufactured by Osko, Inc.. It received FDA 510(k) clearance on 2020-06-29 under approval number K201503. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edge Air(1417) Digital Flat Panel X-ray Detector?

Edge Air(1417) Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Osko, Inc.. The 510(k) number is K201503.

When was Edge Air(1417) Digital Flat Panel X-ray Detector approved by the FDA?

Edge Air(1417) Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2020-06-29, under approval number K201503.

What company makes Edge Air(1417) Digital Flat Panel X-ray Detector?

Edge Air(1417) Digital Flat Panel X-ray Detector is manufactured by Osko, Inc..

What is the FDA product code for Edge Air(1417) Digital Flat Panel X-ray Detector?

The FDA product code for Edge Air(1417) Digital Flat Panel X-ray Detector is MQB.

Other Devices by Osko, Inc.

K172682Edge Digital Flat Panel X-ray Detector K172681Edge Air Digital Flat Panel X-ray Detector K163048Smart Stitching Software System, Image Processing, Radiological

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.

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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