Portable X-Ray Unit
by General X-Ray, Inc. 3 variants
510(k) K790512
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790512 | Date26 Mar 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 6 Oct 2026
The Portable X-Ray Unit is a mobile X-ray system designed for diagnostic imaging applications. It functions as a radiology device used to capture radiographic images in various clinical settings.
This device is classified as a Class II medical device under regulation number 892.1720. It received FDA 510(k) clearance under K790512.
Other devices from General X-Ray, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the primary function of the Portable X-Ray Unit?
The Portable X-Ray Unit is a mobile radiology device designed to capture radiographic images in various clinical settings.
How is this device classified for regulatory purposes?
This device is classified as a Class II medical device under regulation number 892.1720.
What is the regulatory authorization status for this device?
The device received FDA 510(k) clearance under K790512, which indicates it was found to be substantially equivalent to a predicate device.