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 |