Carestream Health, Inc.: FDA filings under this applicant name
FDA lists 53 510(k) clearances under the applicant name “Carestream Health, Inc.” (first 2008, latest 2026), plus 2 PMA decisions, across 13 product codes in 2 review panels. Median 510(k) review time under this name: 99 days. Since 2017 the median was 100 days, against 106 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 154 |
| 2013 | 2 | 102 |
| 2014 | 3 | 119 |
| 2015 | 6 | 89 |
| 2016 | 3 | 109 |
| 2017 | 3 | 100 |
| 2018 | 4 | 54 |
| 2019 | 5 | 79 |
| 2020 | 4 | 36 |
| 2021 | 1 | 219 |
| 2022 | 2 | 118 |
| 2023 | 1 | 29 |
| 2024 | 2 | 179 |
| 2025 | 1 | 142 |
| 2026 | 2 | 232 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carestream Health, Inc. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 15 | 15 |
| KPR | System, X-Ray, Stationary | 11 | 11 |
| LLZ | System, Image Processing, Radiological | 9 | 9 |
| IZL | System, X-Ray, Mobile | 7 | 7 |
| EIA | Unit, Operative Dental | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 2 | 2 |
| LMC | Camera, Multi Format, Radiological | 2 | 2 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Carestream Health, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | IZL | 2026-03-11 | 166 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | KPR | 2026-01-20 | 298 |
| K251168 | Image Suite | LLZ | 2025-09-04 | 142 |
| K241505 | DRX-Revolution Mobile X-ray System | IZL | 2024-12-10 | 196 |
| K233381 | DRX-Evolution Plus System | KPR | 2024-03-12 | 162 |
| K223842 | DRX - Compass | KPR | 2023-01-20 | 29 |
| K213568 | DRX-Rise Mobile X-ray System | IZL | 2022-03-23 | 134 |
| K213307 | Eclipse II with Smart Noise Cancellation | MQB | 2022-01-14 | 102 |
| K202441 | Eclipse II with Smart Noise Cancellation | MQB | 2021-04-02 | 219 |
| K203159 | Lux 35 Detector | MQB | 2020-12-02 | 40 |
43 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P080018 | PMA | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | 2010-11-03 |
| P030007 | PMA | KODAK MAMMOGRAPHY CAD ENGINE | 2004-11-23 |
Recalls
92 product recalls in 35 recall events; 3 initiated in the last five years. Most recent: 2023-10-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Carestream Health, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03030872: Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion (Completed, started 2017-01-07)
- NCT02531646: Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis (Completed, started 2015-11)
- NCT02445287: Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT) (Completed, started 2015-09)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carestream Dental, LLC (1 510(k)s)
- Carestream Heatlh, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carestream Health, Inc.?
FDA lists 53 510(k) clearances under the applicant name “Carestream Health, Inc.” (first 2008, latest 2026), plus 2 PMA decisions, across 13 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carestream Health, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carestream Health, Inc. is 99 days. Since 2017: 100 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carestream Health, Inc.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 15); KPR (System, X-Ray, Stationary, 11); LLZ (System, Image Processing, Radiological, 9).
Next steps
- See all 53 Carestream Health, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Carestream Health, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.