Sedecal Odyssey
Sedecal Odyssey (2450) is a Class II device made by Sedecal., Sa., cleared under FDA 510(k) K192011 on 25 Sep 2019 and listed in FDA GUDID since 21 Mar 2025 (UDI-DI 08436046003682), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08436046003682 | Date21 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192011 | Date25 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 08436046003682
- FDA 510(k) database K192011
Across registries
- FDA 510(k) K192011 decided 25 Sep 2019 Active
- FDA GUDID UDI-DI 08436046003682 listed 21 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K192011
- Listed FDA GUDID 08436046003682
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- Withdrawn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
- ODYSSEY, 2450
- Primary DI / UDI-DI
- 08436046003682
- 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.