Podiatry X-Ray System
510(k) K133959
Podiatry X-Ray System is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K133959 on 22 Jan 2015, 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 | NumberK133959 | Date22 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K133959
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- Withdrawn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
Devices cleared under K133959
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 2020 Imaging Podiatry System HF XR410i | PXS-710 / XR410i | 00817100020148 | — | On the market |
| PXS-710D | 900100 / PXS-710D | 00868162000296 | — | On the market |
Similar devices
Other devices filed under FDA product code KPR (System, X-Ray, Stationary).
- SHOULDER RETRACTOR by Northwest Medical Physics Center
- YSIO X.pree by SIEMENS MEDICAL SOLUTIONS USA, INC.
- DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector by CARESTREAM HEALTH, INC.
- HFG 350, 650, 1050 by Varian Canada, Inc.
- VIZTEK DR, MODELS: DR1000, DR3000, DR4000 by Viztek, Inc.
- SILHOUETTE FC by GE MEDICAL SYSTEMS, INC.
- WHITMORE ANKLE X-RAY EXTENSION (AXE) by Whitmore Ent., Inc.
- VRT TABLE W/INTEGRATING TUBE STAND/ELEV by General Electric Co.
- A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH by M. C. JOHNSON CO., INC.
- C-ARM X-RAY SYSTEM by General Electric Co.