Soltus 500
510(k) K192936
Soltus 500 is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Sedecal., Sa., cleared under FDA 510(k) K192936 on 15 Nov 2019, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192936 | Date15 Nov 2019 | StatusActive |
Official records
- FDA 510(k) database K192936
Recalls
-
- Ongoing Z-0182-2023
Due to un-commanded movement of mobile x-ray unit.
Timeline
- Cleared FDA 510(k) K192936
- Recall initiated FDA recalls Z-0182-2023
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- Withdrawn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 K192936
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 | |||
|---|---|---|---|---|
| SEDECAL Soltus 450 | 10451-01 / Soltus 450 | 08436046002562 | — | On the market |
| SEDECAL Soltus 450 | 10451-02 / Soltus 450 | 08436046002531 | — | On the market |
| SEDECAL Soltus 450 | 10451-03 / Soltus 450 | 08436046002548 | — | On the market |
| SEDECAL Soltus 450 | 10451 / Soltus 450 | 08436046002555 | — | On the market |
| SEDECAL Soltus 500 | 10501-1 / Soltus 500 | 08436046002463 | — | On the market |
| SEDECAL Soltus 500 | 10501-3 / Soltus 500 | 08436046002449 | — | On the market |
| SEDECAL Soltus 500 | 10501 / Soltus 500 | 08436046002456 | — | On the market |
Similar devices
Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
- 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.
- EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) by Sedecal USA, Inc.
- EzRay M (Model: VMX-P300) by VATECH CO., LTD.
- Sirius Starmobile tiara by Hitachi Medical Systems America, Inc.
- GENERAL ELECTRIC AMX II by Pro-Tronics, Inc.
- Digital Diagnostic Mobile X-ray System by Samsung Electronics Co.,Ltd
- MOBIL-AID AUTOMATIC EXPOSURE CONTROL by Advanced Instrument Development, Inc.
- GENERAL EQUIPMENT COVER by Contour Fabricators, Inc.