Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carestream Health, Inc. · Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
214 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251168 | Image Suite | Carestream Health, Inc. | 2025-09-04 | 142 | 0 |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024-12-10 | 196 | 0 |
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024-03-12 | 162 | 0 |
| K223842 | DRX - Compass | Carestream Health, Inc. | 2023-01-20 | 29 | 0 |
| K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | 2022-01-14 | 102 | 0 |
| K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | 2021-04-02 | 219 | 0 |
| K201373 | DRX-Compass | Carestream Health, Inc. | 2020-06-26 | 31 | 1 |
| K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | 2020-02-18 | 130 | 0 |
| K193574 | Q-Rad System | Carestream Health, Inc. | 2020-01-22 | 30 | 0 |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Carestream Health, Inc. | 2019-12-20 | 158 | 0 |
| K190330 | DRX-Evolution/Plus with Dual Energy | Carestream Health, Inc. | 2019-11-04 | 263 | 0 |
| K191025 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2019-05-17 | 29 | 2 |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. | 2019-02-08 | 79 | 0 |
| K183474 | Carestream DRX-1 System with DRX Core Detectors | Carestream Health, Inc. | 2019-01-16 | 30 | 0 |
| K180809 | Eclipse II | Carestream Health, Inc. | 2018-06-21 | 85 | 0 |
| K180667 | SmartGrid | Carestream Health, Inc. | 2018-04-13 | 30 | 0 |
| K173924 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2018-02-05 | 41 | 0 |
| K173478 | OnSight 3D Extremity System | Carestream Health, Inc. | 2018-01-19 | 67 | 0 |
| K170755 | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc. | 2017-06-21 | 100 | 0 |
| K170580 | Carestream Vue PACS | Carestream Health, Inc. | 2017-04-11 | 42 | 0 |
| K163203 | Carestream DRX-Evolution | Carestream Health, Inc. | 2016-12-13 | 28 | 0 |
| K160723 | OnSight 3D Extremity System | Carestream Health, Inc. | 2016-08-30 | 167 | 0 |
| K153103 | CARESTREAM Vue PACS | Carestream Health, Inc. | 2016-02-12 | 109 | 1 |
| K152467 | Touch Ultrasound | Carestream Health, Inc. | 2015-12-09 | 100 | 2 |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Carestream Health, Inc. | 2015-11-25 | 26 | 0 |
| K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015-09-21 | 82 | 1 |
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015-06-24 | 92 | 0 |
| K150342 | Touch Ultrasound | Carestream Health, Inc. | 2015-05-08 | 86 | 0 |
| K141837 | DRX-EVOLUTION | Carestream Health, Inc. | 2015-03-11 | 247 | 1 |
| K140271 | TABLET VIEWER SOFTWARE FOR IMAGE SUITE | Carestream Health, Inc. | 2014-04-01 | 57 | 0 |
| K133442 | BONE SUPPRESSION SOFTWARE | Carestream Health, Inc. | 2014-03-11 | 119 | 0 |
| K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLI | Carestream Health, Inc. | 2014-02-06 | 150 | 0 |
| K130567 | DR LONG LENGTH IMAGING SOFTWARE | Carestream Health, Inc. | 2013-06-11 | 99 | 0 |
| K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR | Carestream Health, Inc. | 2013-06-07 | 105 | 0 |
| K122523 | CARESTREAM VUE PACS | Carestream Health, Inc. | 2012-10-23 | 64 | 0 |
| K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR | Carestream Health, Inc. | 2012-08-28 | 214 | 0 |
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM | Carestream Health, Inc. | 2012-04-13 | 95 | 6 |
| K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | 2012-03-02 | 284 | 0 |
| K112321 | CS 1200 | Carestream Health, Inc. | 2011-11-10 | 90 | 0 |
| K110919 | CARESTREAM PACS | Carestream Health, Inc. | 2011-10-20 | 202 | 50 |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | Carestream Health, Inc. | 2011-10-06 | 122 | 0 |
| K111649 | CS 7600 | Carestream Health, Inc. | 2011-09-23 | 102 | 0 |
| K091186 | KODAK 1500 INTRAORAL CAMERA | Carestream Health, Inc. | 2009-08-18 | 117 | 0 |
| K091889 | DRX-EVOLUTION, MODEL VX3733-SYS | Carestream Health, Inc. | 2009-07-20 | 26 | 3 |
| K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | Carestream Health, Inc. | 2009-05-22 | 88 | 0 |
| K090318 | CARESTREAM DRX-1 SYSTEM | Carestream Health, Inc. | 2009-04-06 | 56 | 2 |
| K083673 | CARESTREAM PACS, MODEL CARESTREAM PACS VII | Carestream Health, Inc. | 2008-12-30 | 19 | 0 |
| K081836 | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM | Carestream Health, Inc. | 2008-07-30 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda