Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Carestream Health and its 2 subsidiaries with 87 device recalls, 56 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Mar 11, 2026: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Carestream Health and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 11, 2026 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemK253185 · IZL | 510(k) clearances |
| Jan 20, 2026 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorK250954 · KPR | 510(k) clearances |
| Sep 4, 2025 | Image SuiteK251168 · LLZ | 510(k) clearances |
| Dec 10, 2024 | DRX-Revolution Mobile X-ray SystemK241505 · IZL | 510(k) clearances |
| Mar 12, 2024 | DRX-Evolution Plus SystemK233381 · KPR | 510(k) clearances |
| Jan 20, 2023 | DRX - CompassK223842 · KPR | 510(k) clearances |
| Mar 23, 2022 | DRX-Rise Mobile X-ray SystemK213568 · IZL | 510(k) clearances |
| Jan 14, 2022 | Eclipse II with Smart Noise CancellationK213307 · MQB | 510(k) clearances |
| Jan 14, 2022 | Eclipse II with Smart Noise CancellationK213307 · Radiology | AI-enabled devices |
| Apr 2, 2021 | Eclipse II with Smart Noise CancellationK202441 · Radiology | AI-enabled devices |
| Feb 15, 2021 | Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of Class II · The mirror may become detached and fall from the unit | Device recalls |
| Sep 2, 1998 | LOGICON CARIES DETECTORP980025 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
