Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Minxray, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
123 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210479 | IMPACT and X-Ranger | Minxray, Inc. | 2021-03-19 | 28 | 0 |
| K201575 | CMDR 2C (Multiple Models) | Minxray, Inc. | 2020-07-08 | 27 | 0 |
| K191451 | CMDR 2CW (Multiple models) | Minxray, Inc. | 2019-07-03 | 33 | 0 |
| K182207 | TR90BH | Minxray, Inc. | 2018-12-14 | 121 | 0 |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Int | Minxray, Inc. | 2017-06-07 | 29 | 0 |
| K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016-02-02 | 104 | 0 |
| K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | Minxray, Inc. | 2014-09-18 | 69 | 0 |
| K091255 | MINXRAY, MODEL: BPD60 | Minxray, Inc. | 2010-05-12 | 378 | 0 |
| K100449 | MINXRAY MODEL CMDR-2S | Minxray, Inc. | 2010-04-23 | 65 | 0 |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | Minxray, Inc. | 2008-11-07 | 59 | 0 |
| K052721 | MINXRAY, MODEL HF100H+ | Minxray, Inc. | 2005-10-27 | 28 | 0 |
| K040046 | MINXRAY, MODEL HF120/60H POWERPLUS | Minxray, Inc. | 2004-02-02 | 21 | 0 |
| K000061 | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT | Minxray, Inc. | 2000-04-07 | 88 | 0 |
| K973712 | MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | Minxray, Inc. | 1997-12-12 | 74 | 0 |
| K945707 | MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | Minxray, Inc. | 1995-01-19 | 59 | 0 |
| K911841 | MINXRAY P300 X-RAY SYSTEM | Minxray, Inc. | 1991-08-26 | 123 | 0 |
| K854510 | MINXRAY 500M MAMMOGRAPHIC SYSTEM | Minxray, Inc. | 1986-01-01 | 50 | 0 |
| K760741 | PORTABLE X-RAY | Minxray, Inc. | 1976-10-05 | 5 | 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