FDA 510(k)

OTC DDR

K-Number: K221853 · 2022-07-27

ApplicantKonica Minolta Healthcare Americas, Inc.

Decision Date2022-07-27

Product CodeKPR

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OTC DDR is a medical device manufactured by Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2022-07-27 under approval number K221853. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTC DDR?

OTC DDR is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K221853.

When was OTC DDR approved by the FDA?

OTC DDR received FDA 510(k) clearance on 2022-07-27, under approval number K221853.

What company makes OTC DDR?

OTC DDR is manufactured by Konica Minolta Healthcare Americas, Inc..

What is the FDA product code for OTC DDR?

The FDA product code for OTC DDR is KPR.

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 K214030Universal DR 1748 K214012Straight Arm DDR

Related Devices (Code: KPR)

K163203Carestream DRX-EvolutionCarestream Health, Inc. K163115GC70Samsung Electronics Co., Ltd. K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd. K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. K161937CuattroDRCuattro, LLC K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.

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.