WBR, Model HR
by U.C.G. Technologies, Ltd. 510(k)
Active
510(k) K030870
Overview
The device is a System, Tomography, Computed, Emission, as defined in the device data. It is substantially equivalent to a predicate device and received FDA 510(k) clearance under product code KPS and regulation number 892.1200.
It is manufactured by U.C.G. Technologies, Ltd. and was cleared on April 9, 2003. The device is used in radiology settings and is supplied as a non-sterile, reusable system. No information on sterility, single-use status, MRI safety, sizes, or storage is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030870 | Date9 Apr 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KPS
- FDA applicant
- U.C.G. Technologies , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from U.C.G. Technologies, Ltd.
Questions
What is the WBR, MODEL HR device used for?
The WBR, MODEL HR is a System, Tomography, Computed, Emission used in radiology settings for imaging purposes, as defined by its FDA 510(k) clearance under product code KPS and regulation number 892.1200.
Is the WBR, MODEL HR sterile or single-use?
The WBR, MODEL HR is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is intended for multiple uses after appropriate cleaning and reprocessing.
When was the WBR, MODEL HR cleared by the FDA?
The WBR, MODEL HR received FDA 510(k) clearance on April 9, 2003, under submission number K030870, confirming its substantial equivalence to a legally marketed predicate device.
Who manufactures the WBR, MODEL HR and where is it based?
The WBR, MODEL HR is manufactured by U.C.G. Technologies, Ltd., located in Haifa, Israel, with the facility address at Bldg. 30 Matam and postal code 31905.