Portable X-Ray
510(k) K760741
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760741 | Date5 Oct 1976 | StatusActive |
Official records
- FDA 510(k) database K760741
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- Withdrawn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
Overview
AI-generated summary, 23 Sep 2026
The Portable X-Ray is a mobile X-ray system designed for radiology applications. It is a Class II medical device that allows for X-ray imaging to be performed at the patient's location rather than requiring the patient to be transported to a fixed imaging facility.
The Portable X-Ray is supplied by Minxray, Inc. and has received FDA 510(k) clearance with the K number K760741. It is regulated under product code IZL and regulation number 892.1720. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- SEDECAL by Sedecal., Sa.
- BONX805 by BONTECH Co., Ltd.
- AMX Navigate 5844925 by GE Medical Systems, L.L.C.
- AJEX 9015/135H PORTABLE X-RAY by Jpi America, Inc.
- Paragon 2 by Meridian Medical Systems, LLC
- BCM-ARC 105 X-RAY MOBILE UNIT by B C Medical, Ltd.
- PORT-XP by Mobile Dental Equipment Corp.
- MX40 Mobile Digital X-ray System by HUESTIS MACHINE CORP.
- PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. by Sedecal., Sa.
- STERILE CONTINER, X-RAY CASSETTE HOLDER by North Shore Orthopaedic Group, S.C.