The following data is part of a premarket notification filed by Orthoscan Ltd. with the FDA for Ortelius 800.
| Device ID | K011827 |
| 510k Number | K011827 |
| Device Name: | ORTELIUS 800 |
| Classification | Goniometer, Ac-powered |
| Applicant | ORTHOSCAN LTD. 17 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman ORTHOSCAN LTD. 17 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-08-28 |
| Summary: | summary |