The following data is part of a premarket notification filed by Medic Vision Imaging Solutions with the FDA for Safect-29.
| Device ID | K153331 |
| 510k Number | K153331 |
| Device Name: | SafeCT-29 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | MEDIC VISION IMAGING SOLUTIONS 3 YOZMA Tirat Carmel, IL 3903203 |
| Contact | Eyal Aharon |
| Correspondent | Dan Laor MEDIC VISION IMAGING SOLUTIONS 6 SIRENI Haifa, IL 32972 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016836202 | K153331 | 000 |