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FDA 510(k)

SKR 4000

K-Number: K191645 · 2019-08-16

ApplicantKonica Minolta, Inc.
Decision Date2019-08-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SKR 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191645. 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 SKR 4000?

SKR 4000 is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K191645.

When did SKR 4000 receive FDA 510(k) clearance?

SKR 4000 received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191645.

Who is the listed applicant for SKR 4000?

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

What is the FDA product code for SKR 4000?

The FDA product code for SKR 4000 is MQB.

Other records listing Konica Minolta, 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.

K250665SKR 3000K241319SKR 3000K240281Bone Suppression SoftwareK230906Konicaminolta DI-X1K223267SKR 3000K220993Ultrasound System SONIMAGE MX1

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Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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