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FDA 510(k)

DRX-Evolution with Carestream Digital Tomosynthesis

K-Number: K191879 · 2019-12-20

ApplicantCarestream Health, Inc.
Decision Date2019-12-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Evolution with Carestream Digital Tomosynthesis is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K191879. 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 DRX-Evolution with Carestream Digital Tomosynthesis?

DRX-Evolution with Carestream Digital Tomosynthesis is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Carestream Health, Inc.. The 510(k) number is K191879.

When was DRX-Evolution with Carestream Digital Tomosynthesis approved by the FDA?

DRX-Evolution with Carestream Digital Tomosynthesis received FDA 510(k) clearance on 2019-12-20, under approval number K191879.

What company makes DRX-Evolution with Carestream Digital Tomosynthesis?

DRX-Evolution with Carestream Digital Tomosynthesis is manufactured by Carestream Health, Inc..

What is the FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis?

The FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis is KPR.

Related Clinical Trials

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Related PubMed Literature

PMID: 40271230 When Software Becomes Medicine: Ignoring It May Soon Be Malpractice. Cureus (2025)

Other Devices by Carestream Health, Inc.

K163203Carestream DRX-Evolution K160723OnSight 3D Extremity System K153103CARESTREAM Vue PACS K170755DRX-Revolution Nano Mobile X-ray System K170580Carestream Vue PACS K180809Eclipse II

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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

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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