The following data is part of a premarket notification filed by Medic Vision Brain Technologies Ltd with the FDA for Safect Model Ver 1.0.
| Device ID | K100372 |
| 510k Number | K100372 |
| Device Name: | SAFECT MODEL VER 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIC VISION BRAIN TECHNOLOGIES LTD 6 SIRENI Haifa, IL 32972 |
| Contact | Dan Laor |
| Correspondent | Dan Laor MEDIC VISION BRAIN TECHNOLOGIES LTD 6 SIRENI Haifa, IL 32972 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2010-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016836004 | K100372 | 000 |