Minxray Inc
Northbrook, IL, US
MINXRAY, INC. appears in FDA device records in Northbrook, IL. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Minxray Inc between 1976 and 2021. The busiest year on record is 2010, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1986 | 1 |
| 1991 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2010 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210479 | IMPACT and X-Ranger | IZL | Substantially Equivalent | |
| K201575 | CMDR 2C (Multiple Models) | IZL | Substantially Equivalent | |
| K191451 | CMDR 2CW (Multiple models) | IZL | Substantially Equivalent | |
| K182207 | TR90BH | IZL | Substantially Equivalent | |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | IZL | Substantially Equivalent | |
| K153059 | HF1202H PowerPlus Portable X-ray Equipment | IZL | Substantially Equivalent | |
| K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | IZL | Substantially Equivalent | |
| K091255 | MINXRAY, MODEL: BPD60 | EHD | Substantially Equivalent | |
| K100449 | MINXRAY MODEL CMDR-2S | IZL | Substantially Equivalent | |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | IZL | Substantially Equivalent | |
| K052721 | MINXRAY, MODEL HF100H+ | IZL | Substantially Equivalent | |
| K040046 | MINXRAY, MODEL HF120/60H POWERPLUS | IZL | Substantially Equivalent | |
| K000061 | MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT | EHD | Substantially Equivalent | |
| K973712 | MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | IZL | Substantially Equivalent | |
| K945707 | MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | IZL | Substantially Equivalent | |
| K911841 | MINXRAY P300 X-RAY SYSTEM | IZL | Substantially Equivalent | |
| K854510 | MINXRAY 500M MAMMOGRAPHIC SYSTEM | IZH | Substantially Equivalent | |
| K760741 | PORTABLE X-RAY | IZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1418960 | 1418960 | MINXRAY, INC. | 3611 COMMERCIAL AVE., NORTHBROOK, IL 60062 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0986-04 | MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A. | The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information. | Terminated | ||
| Z-0985-04 | MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A. | The x-ray units are defective under 21 CFR 1020.30(h) in that the user manual had missing or inadequate information. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain