SEDECAL Soltus 450
SEDECAL Soltus 450 (10451-02) is a Class II device made by Sedecal., Sa., cleared under FDA 510(k) K192936 on 15 Nov 2019 and listed in FDA GUDID since 23 Jul 2020 (UDI-DI 08436046002531), active as of 23 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 | GUDID listing | Number08436046002531 | Date23 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192936 | Date15 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 08436046002531
- FDA 510(k) database K192936
Across registries
- FDA 510(k) K192936 decided 15 Nov 2019 Active
- FDA GUDID UDI-DI 08436046002531 listed 23 Jul 2020 Listed
Recalls
-
- Ongoing Z-0182-2023
Due to un-commanded movement of mobile x-ray unit.
Timeline
- Cleared FDA 510(k) K192936
- Listed FDA GUDID 08436046002531
- Recall initiated FDA recalls Z-0182-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sedecal
- Generic name
- Mobile basic diagnostic x-ray system, digital
- Model / Ref / Catalog
- Soltus 450, 10451-02
- Primary DI / UDI-DI
- 08436046002531
- 510(k) Number
- FDA product code
- MQB, IZL
- GMDN term
- Mobile basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1680, 892.1720
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Mobile basic diagnostic x-ray system, digital.