SpotLight Duo
SpotLight Duo is a Class II device made by Arineta, Ltd., cleared under FDA 510(k) K213465 on 2 Dec 2022 and listed in FDA GUDID since 7 Sep 2023 (UDI-DI 07290016484021), 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 | GUDID listing | Number07290016484021 | Date7 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213465 | Date2 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 07290016484021
- FDA 510(k) database K213465
Across registries
- FDA 510(k) K213465 decided 2 Dec 2022 Active
- FDA GUDID UDI-DI 07290016484021 listed 7 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K213465
- Listed FDA GUDID 07290016484021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Full-body CT system
- Model / reference
- SpotLight
- Primary DI / UDI-DI
- 07290016484021
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Full-body CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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