Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K202995X-ray Flat Panel Detectors/CareView 3600RFCareray Digital Medical System Co., Ltd.2021-02-191410
K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500CCareray Digital Medical System Co., Ltd.2020-08-07250
K193173CareView 1800LeCareray Digital Medical System Co., Ltd.2019-12-13250
K172581CareView 1800Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.2017-09-26290
K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.2016-12-01310
K162178CareView 1500P X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.2016-09-01280
K153492CareView 1800LCareray Digital Medical System Co., Ltd.2015-12-24200
K153058CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.2015-11-10200
K141488CAREVIEW 1800RCareray Digital Medical System Co., Ltd.2015-09-084600
K150929CareView 1500Cw X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.2015-08-041200

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