The following data is part of a premarket notification filed by Orthocrat, Ltd. with the FDA for Traumacad 1.2.
| Device ID | K042816 |
| 510k Number | K042816 |
| Device Name: | TRAUMACAD 1.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | ORTHOCRAT, LTD. 34/3 BAR KOHVA ST. Tel Aviv, IL 63427 |
| Contact | Adi Ickowicz |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-11-10 |
| Summary: | summary |