The following data is part of a premarket notification filed by Voyant Health Ltd with the FDA for Traumacad Mobile Release 2.0.
| Device ID | K160001 |
| 510k Number | K160001 |
| Device Name: | TraumaCad Mobile Release 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Voyant Health Ltd 35 Efal Street Petach-tikva, IL 4951132 |
| Contact | Yael Guttentag |
| Correspondent | Yael Guttentag Voyant Health Ltd 35 Efal Street Petach-tikva, IL 4951132 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-04 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109942001 | K160001 | 000 |