The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 1.0t 8-channel Panorama Breast Array Coil.
| Device ID | K093284 |
| 510k Number | K093284 |
| Device Name: | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY 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 | 2009-10-20 |
| Decision Date | 2010-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838066823 | K093284 | 000 |