Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Careray Digital Medical System Co., Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
460 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | Careray Digital Medical System Co., Ltd. | 2021-02-19 | 141 | 0 |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500C | Careray Digital Medical System Co., Ltd. | 2020-08-07 | 25 | 0 |
| K193173 | CareView 1800Le | Careray Digital Medical System Co., Ltd. | 2019-12-13 | 25 | 0 |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2017-09-26 | 29 | 0 |
| K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2016-12-01 | 31 | 0 |
| K162178 | CareView 1500P X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2016-09-01 | 28 | 0 |
| K153492 | CareView 1800L | Careray Digital Medical System Co., Ltd. | 2015-12-24 | 20 | 0 |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015-11-10 | 20 | 0 |
| K141488 | CAREVIEW 1800R | Careray Digital Medical System Co., Ltd. | 2015-09-08 | 460 | 0 |
| K150929 | CareView 1500Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | 2015-08-04 | 120 | 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