The following data is part of a premarket notification filed by Surgi-vision, Inc. with the FDA for Surgi-vision Prostate Coil.
| Device ID | K002916 |
| 510k Number | K002916 |
| Device Name: | SURGI-VISION PROSTATE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SURGI-VISION, INC. 9250 RUMSEY RD., SUITE 100 Columbia, MD 21045 |
| Contact | Nancy E Taylor |
| Correspondent | Nancy E Taylor SURGI-VISION, INC. 9250 RUMSEY RD., SUITE 100 Columbia, MD 21045 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-19 |
| Decision Date | 2000-11-28 |