DRX-Evolution with Carestream Digital Tomosynthesis
K-Number: K191879 · 2019-12-20
Device Summary
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. The listed applicant is Carestream Health, Inc.. The 510(k) number is K191879.
When did DRX-Evolution with Carestream Digital Tomosynthesis receive FDA 510(k) clearance?
DRX-Evolution with Carestream Digital Tomosynthesis received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191879.
Who is the listed applicant for DRX-Evolution with Carestream Digital Tomosynthesis?
The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Carestream Health, 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.
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.
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.