Q-Rad System
510(k) K193574
Q-Rad System is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K193574 on 22 Jan 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193574 | Date22 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K193574
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- Withdrawn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
Similar devices
Other devices filed under FDA product code KPR (System, X-Ray, Stationary).
- XGEO GC80 by Samsung Electronics Co.,Ltd
- PRORAD 3NC A90-3NC-0001 by Prognosys Medical Systems Private Limited
- DX-D 300 8207/050 5NBXP by Agfa Corp.
- SHIMADZU CEILING TUBE SUPPORT CH-30GX by SHIMADZU CORPORATION
- Refurbish Diagnostic X-Ray Equipment by Chemarts and Assoc., Inc.
- SCX Information Management System by General Electric Co.
- Belmont Podiatry Model 065 X-Ray by Belmont Equipment Corp.
- General Radiography X-ray System (Model: GR10X 40K, GR10X 50K) by XERA Medical Systems and Technology Ltd.
- MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Jumong General by Sg Healthcare Co, Ltd.