FDA 510(k)

Universal DR 1748

K-Number: K214030 · 2022-01-21

ApplicantKonica Minolta Healthcare Americas, Inc.

Decision Date2022-01-21

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Universal DR 1748 is a medical device manufactured by Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2022-01-21 under approval number K214030. 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 Universal DR 1748?

Universal DR 1748 is a medical device that received FDA 510(k) clearance on 2022-01-21. It is manufactured by Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K214030.

When was Universal DR 1748 approved by the FDA?

Universal DR 1748 received FDA 510(k) clearance on 2022-01-21, under approval number K214030.

What company makes Universal DR 1748?

Universal DR 1748 is manufactured by Konica Minolta Healthcare Americas, Inc..

What is the FDA product code for Universal DR 1748?

The FDA product code for Universal DR 1748 is MQB.

Other Devices by Konica Minolta Healthcare Americas, Inc.

K193225KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography K203743EXA K221853OTC DDR K214012Straight Arm DDR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.