The following data is part of a premarket notification filed by Insightech, Ltd with the FDA for Mrgfus Pelvic Pa Coil Model 1.0.
| Device ID | K111060 |
| 510k Number | K111060 |
| Device Name: | MRGFUS PELVIC PA COIL MODEL 1.0 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INSIGHTECH, LTD 5 NAHUM HETH ST. Tirat Carmel, IL 39120 |
| Contact | Ori Lubin |
| Correspondent | Ori Lubin INSIGHTECH, LTD 5 NAHUM HETH ST. Tirat Carmel, IL 39120 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-09-09 |
| Summary: | summary |