Data / Medical devices / United States / Minxray, Inc.
Minxray, Inc.: FDA-registered device maker in Northbrook, IL, United States, 5 510(k) clearances
Minxray, Inc. is registered with the FDA (registration 1418960) in Northbrook, IL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 19, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1418960
- Address
- 3611 Commercial Ave., Northbrook, IL, United States, 60062
- Owner or operator
- The Kretchmer Corp. (9006653)
- Roles
- Manufacturer
- First device listed
- August 18, 2016
- Registered through
- 2026
- Brand names listed
- CMDR.C.100.R, CMDR.C.100.S, CMDR.C.120.60.R, CMDR.C.120.60.S, CMDR.C.1202.R, CMDR.C.1202.S, MinXray CMDR-2SLWT, MinXray CMDR.CW.100.R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2021 | K210479 | IMPACT and X-Ranger | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| July 8, 2020 | K201575 | CMDR 2C (Multiple Models) | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| July 3, 2019 | K191451 | CMDR 2CW (Multiple models) | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| June 7, 2017 | K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | IZL | Substantially Equivalent | Minxray, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 29, 2004 | 29354 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
Updated March 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.