FDA applicant
Carestream Health, Inc.
FDA records 55 decisions for Carestream Health, Inc. (Rochester, NY) from 2004 to 2026: 53 510(k) clearances and 2 original PMA approvals. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 66 predicates, 33 of them its own earlier devices. 71 recalls are linked to its devices.
FDA’s records also spell it “Carestream Health”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carestream Health, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Carestream Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Carestream”
FDA records each applicant name separately; these may or may not be the same firm.