Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DRX - Compass

K-Number: K223842 · 2023-01-20

Decision Date2023-01-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX - Compass 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 2023-01-20 under 510(k) number K223842. 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 - Compass?

DRX - Compass is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Carestream Health, Inc.. The 510(k) number is K223842.

When did DRX - Compass receive FDA 510(k) clearance?

DRX - Compass received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223842.

Who is the listed applicant for DRX - Compass?

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 - Compass?

The FDA product code for DRX - Compass 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.