The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.5t 16-channel Hand-wrist Coil.
| Device ID | K103149 |
| 510k Number | K103149 |
| Device Name: | 1.5T 16-CHANNEL HAND-WRIST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Contact | Elizabeth Wheeler |
| Correspondent | Elizabeth Wheeler INVIVO CORPORATION 3545 SW 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 | 2010-10-25 |
| Decision Date | 2011-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087002 | K103149 | 000 |
| 00884838086159 | K103149 | 000 |
| 00884838081673 | K103149 | 000 |
| 00884838081680 | K103149 | 000 |