The following data is part of a premarket notification filed by Insightec Txsonics, Inc. with the FDA for Mrgfus General Purpose And Breast Coil.
| Device ID | K061715 |
| 510k Number | K061715 |
| Device Name: | MRGFUS GENERAL PURPOSE AND BREAST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INSIGHTEC TXSONICS, INC. 2777 STEMMONS FREEWAY STE 940 Dallas, TX 75207 -2273 |
| Contact | Nadir Alikacem |
| Correspondent | Nadir Alikacem INSIGHTEC TXSONICS, INC. 2777 STEMMONS FREEWAY STE 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 | 2006-06-19 |
| Decision Date | 2006-07-28 |
| Summary: | summary |