FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CMDR 2CW (Multiple models)
K Number: K191451
·
Decision Jul 3, 2019
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
18
Review Days
33
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Basic Information
- Device Name
- CMDR 2CW (Multiple models)
- K Number
- K191451
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minxray, Inc.
- Date Received
- May 31, 2019
- Decision Date
- July 3, 2019
- Product Code
- IZL
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | FDA class 2 | Radiology |
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Other Clearances by Minxray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210479 | IMPACT and X-Ranger | Mar 19, 2021 | Substantially Equivalent |
| K201575 | CMDR 2C (Multiple Models) | Jul 8, 2020 | Substantially Equivalent |
| K182207 | TR90BH | Dec 14, 2018 | Substantially Equivalent |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | Jun 7, 2017 | Substantially Equivalent |
| K153059 | HF1202H PowerPlus Portable X-ray Equipment | Feb 2, 2016 | Substantially Equivalent |
| K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | Sep 18, 2014 | Substantially Equivalent |
| K091255 | MINXRAY, MODEL: BPD60 | May 12, 2010 | Substantially Equivalent |
| K100449 | MINXRAY MODEL CMDR-2S | Apr 23, 2010 | Substantially Equivalent |
| K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | Nov 7, 2008 | Substantially Equivalent |
| K052721 | MINXRAY, MODEL HF100H+ | Oct 27, 2005 | Substantially Equivalent |