CMDR 2CW (Multiple models)
510(k) K191451
CMDR 2CW (Multiple models) is a Class II device made by Minxray, Inc., cleared under FDA 510(k) K191451 on 3 Jul 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191451 | Date3 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K191451
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
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- Rover by Micro-X, Ltd.
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- Mobile X-ray System MobileArt Evolution 566-20000-81 by SHIMADZU CORPORATION
- DX-D 100 by Agfa Healthcare N.V.
- HF-110A by Dynarad Corp.
- X-RAY UNITS, GX-101, UCIS-510 AND GX-111 by General X-Ray, Inc.
- Airbile-100 by Poskom Co., Ltd.