Vmx Mobile X-Ray System
510(k) K910902
Vmx Mobile X-Ray System is a Class II device made by GE Medical Systems, cleared under FDA 510(k) K910902 on 9 Sep 1991, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910902 | Date9 Sep 1991 | StatusActive |
Official records
- FDA 510(k) database K910902
Recalls
-
- Terminated Z-1083-2013
GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety.
Timeline
- Cleared FDA 510(k) K910902
- Recall initiated FDA recalls Z-1083-2013
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- Withdrawn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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- PORTABLE X-RAY UNIT by General X-Ray, Inc.
- PhoeniX by Sedecal., Sa.
- SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES by SHIMADZU CORPORATION
- CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY by Minxray, Inc.