The following data is part of a premarket notification filed by Odin Medical Technologies Ltd. with the FDA for Polestar N-10.
| Device ID | K010850 |
| 510k Number | K010850 |
| Device Name: | POLESTAR N-10 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit, IL 20692 |
| Contact | Adi Ickowicz |
| Correspondent | Adi Ickowicz ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit, IL 20692 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-21 |
| Decision Date | 2001-12-17 |