QV-9000 Universal System
by Quantum Medical Imaging, LLC
510(k) K083181
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083181 | Date26 Nov 2008 | 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- Withdrawn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
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The QV-9000 Universal System is a stationary radiographic imaging system designed for acquiring radiographic images of various anatomical regions of the human body. It functions as a medical imaging system within the field of radiology.
This device is authorized under FDA 510(k) clearance number K083181. It is classified as a stationary X-ray system and is intended for clinical use as specified by the manufacturer.
Other devices from Quantum Medical Imaging, LLC
Questions
AI-generated answers, 22 Sep 2026
What is the primary purpose of the QV-9000 Universal System?
The QV-9000 is a stationary radiographic imaging system intended for clinical use to acquire diagnostic images of various anatomical regions of the human body.
Is this device authorized for clinical use?
Yes, the QV-9000 Universal System is authorized under FDA 510(k) clearance number K083181, which confirms it has been found substantially equivalent to other legally marketed devices.
How is the QV-9000 classified for regulatory purposes?
The device is classified as a stationary X-ray system under regulation number 892.1680, falling under the radiology medical specialty.