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FDA 510(k)

DRX-Evolution Plus System

K-Number: K233381 · 2024-03-12

Decision Date2024-03-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Evolution Plus System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2024-03-12 under 510(k) number K233381. 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 Plus System?

DRX-Evolution Plus System is a medical device that received FDA 510(k) clearance on 2024-03-12. The listed applicant is Carestream Health, Inc.. The 510(k) number is K233381.

When did DRX-Evolution Plus System receive FDA 510(k) clearance?

DRX-Evolution Plus System received FDA 510(k) clearance on 2024-03-12, under 510(k) number K233381.

Who is the listed applicant for DRX-Evolution Plus System?

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 Plus System?

The FDA product code for DRX-Evolution Plus System 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.

View all 28 devices →

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.