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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 the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta Healthcare Americas, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) 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. The listed applicant is Konica Minolta Healthcare Americas, Inc.. The 510(k) number is K221853.

When did OTC DDR receive FDA 510(k) clearance?

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

Who is the listed applicant for OTC DDR?

The FDA 510(k) record lists Konica Minolta Healthcare Americas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC DDR?

The FDA product code for OTC DDR is KPR.

Other records listing Konica Minolta Healthcare Americas, Inc. as applicant

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.

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Related Devices (Code: KPR)

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.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems Co. , 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.

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