Edge Digital Flat Panel X-ray Detector
K-Number: K172682 · 2017-10-06
ApplicantOsko, Inc.
Decision Date2017-10-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Edge Digital Flat Panel X-ray Detector is a medical device manufactured by Osko, Inc.. It received FDA 510(k) clearance on 2017-10-06 under approval number K172682. 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 Digital Flat Panel X-ray Detector?
Edge Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2017-10-06. It is manufactured by Osko, Inc.. The 510(k) number is K172682.
When was Edge Digital Flat Panel X-ray Detector approved by the FDA?
Edge Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2017-10-06, under approval number K172682.
What company makes Edge Digital Flat Panel X-ray Detector?
Edge Digital Flat Panel X-ray Detector is manufactured by Osko, Inc..
What is the FDA product code for Edge Digital Flat Panel X-ray Detector?
The FDA product code for Edge Digital Flat Panel X-ray Detector is MQB.
Other Devices by Osko, Inc.
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.