Sr-130
510(k) K030494
Sr-130 is a Class II device made by Source-Ray, Inc., cleared under FDA 510(k) K030494 on 20 May 2003, 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 | NumberK030494 | Date20 May 2003 | StatusActive |
Official records
- FDA 510(k) database K030494
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- Withdrawn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
Devices cleared under K030494
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 | |||
|---|---|---|---|---|
| Portable X-Ray System XR300 | XR300 | 00817100020117 | — | On the market |
| Portable X-Ray System XR301 | XR301 | 00817100020353 | — | On the market |
| SR-130-C | 910002 / SR-130-C | 00868162000258 | — | On the market |
| SR-130-G | 910056 / SR-130-G | 00868162000241 | — | On the market |
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- Rover by Micro-X, Ltd.
- GM60A-32S & GM60A-40S by Samsung Electronics Co.,Ltd
- Mobile X-ray System MobileArt Evolution 566-20000-81 by SHIMADZU CORPORATION
- DX-D 100 by Agfa Healthcare N.V.
- HF-110A by Dynarad Corp.
- X-RAY UNITS, GX-101, UCIS-510 AND GX-111 by General X-Ray, Inc.
- Airbile-100 by Poskom Co., Ltd.
- Topaz Mobile DR System by DRGEM Corporation
- MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM by Shimadzu Medical Systems
- OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM by SIEMENS MEDICAL SOLUTIONS USA, INC.