The following data is part of a premarket notification filed by Arineta Ltd. with the FDA for Spotlight Ct.
| Device ID | K161066 |
| 510k Number | K161066 |
| Device Name: | SpotLight CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Arineta Ltd. 15 Halamish Street Caesarea, IL 3088900 |
| Contact | Ehud Dafni |
| Correspondent | Ehud Dafni Arineta Ltd. 15 Halamish Street Caesarea, IL 3088900 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016484007 | K161066 | 000 |