SpotLight CT
510(k) K161066
SpotLight CT is a Class II device made by Arineta, Ltd., cleared under FDA 510(k) K161066 on 10 Aug 2016, 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 | NumberK161066 | Date10 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161066
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- FDA applicant
- Arineta , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161066
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 | |||
|---|---|---|---|---|
| CardioGraphe Spotlight | Spotlight | 07290016484007 | — | On the market |
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Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).
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