The following data is part of a premarket notification filed by Invivo with the FDA for 1.5t 8-channel Small Extremity Coil, Model 800494, 3.0t 8-channel Small Extremity Coil, Model 800484.
| Device ID | K091902 |
| 510k Number | K091902 |
| Device Name: | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler INVIVO 3545 S.W. 47TH AVE. Gainesville, FL 32608 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-25 |
| Decision Date | 2009-08-21 |
| Summary: | summary |