The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645.
| Device ID | K122897 |
| 510k Number | K122897 |
| Device Name: | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE Gainesville, FL 32608 |
| Contact | Lance Aulabaugh |
| Correspondent | Lance Aulabaugh 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 | 2012-09-21 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082861 | K122897 | 000 |
| 00884838065895 | K122897 | 000 |
| 00884838065901 | K122897 | 000 |
| 00884838066878 | K122897 | 000 |
| 00884838066953 | K122897 | 000 |
| 00884838066960 | K122897 | 000 |
| 00884838082816 | K122897 | 000 |
| 00884838082823 | K122897 | 000 |
| 00884838082830 | K122897 | 000 |
| 00884838082847 | K122897 | 000 |
| 00884838082854 | K122897 | 000 |
| 00884838065888 | K122897 | 000 |