The following data is part of a premarket notification filed by Imactis, Sas with the FDA for Imactis Ct-navigation System.
| Device ID | K162314 |
| 510k Number | K162314 |
| Device Name: | IMACTIS CT-Navigation System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | IMACTIS, SAS 5 AVENUE DU GRAND SABLON La Tronche, FR 38700 |
| Contact | Mady Batailh |
| Correspondent | Mady Batailh IMACTIS, SAS 5 AVENUE DU GRAND SABLON La Tronche, FR 38700 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-18 |
| Decision Date | 2018-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B681J020000 | K162314 | 000 |
| B681J001971 | K162314 | 000 |
| B681J00099US0 | K162314 | 000 |
| B681I101002 | K162314 | 000 |
| B681A102001 | K162314 | 000 |
| B681A100101 | K162314 | 000 |