Minxray, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Minxray, Inc.” (first 1976, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 59 days. Since 2017 the median was 29 days, against 85 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 69 |
| 2015 | 0 | — |
| 2016 | 1 | 104 |
| 2017 | 1 | 29 |
| 2018 | 1 | 121 |
| 2019 | 1 | 33 |
| 2020 | 1 | 27 |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Minxray, Inc. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 85 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 15 | 15 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
Review panels
- Radiology (18)
Most recent Minxray, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210479 | IMPACT and X-Ranger | IZL | 2021-03-19 | 28 |
| K201575 | CMDR 2C (Multiple Models) | IZL | 2020-07-08 | 27 |
| K191451 | CMDR 2CW (Multiple models) | IZL | 2019-07-03 | 33 |
| K182207 | TR90BH | IZL | 2018-12-14 | 121 |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | IZL | 2017-06-07 | 29 |
| K153059 | HF1202H PowerPlus Portable X-ray Equipment | IZL | 2016-02-02 | 104 |
| K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | IZL | 2014-09-18 | 69 |
| K091255 | MINXRAY, MODEL: BPD60 | EHD | 2010-05-12 | 378 |
| K100449 | MINXRAY MODEL CMDR-2S | IZL | 2010-04-23 | 65 |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | IZL | 2008-11-07 | 59 |
8 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-06-29.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Minxray, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Minxray, Inc.” (first 1976, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Minxray, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minxray, Inc. is 59 days. Since 2017: 29 days, versus 85 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Minxray, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 15); EHD (Unit, X-Ray, Extraoral With Timer, 2); IZH (System, X-Ray, Mammographic, 1).
Next steps
- See all 18 Minxray, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Minxray, 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.