The following data is part of a premarket notification filed by Insightec-txsonics, Inc. with the FDA for 1.5t Mrgfus Pelvic Coil.
| Device ID | K071966 |
| 510k Number | K071966 |
| Device Name: | 1.5T MRGFUS PELVIC COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INSIGHTEC-TXSONICS, INC. 2777 N. STEMMONS FREEWAY SUITE 940 Dallas, TX 75207 -2273 |
| Contact | Nadir Alikacem |
| Correspondent | Nadir Alikacem INSIGHTEC-TXSONICS, INC. 2777 N. STEMMONS FREEWAY SUITE 940 Dallas, TX 75207 -2273 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-16 |
| Decision Date | 2007-09-05 |
| Summary: | summary |