The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Ds Breast 16ch I/t 1.5t Ds Breast 16ch I/t 3.0t.
| Device ID | K122646 |
| 510k Number | K122646 |
| Device Name: | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville, FL 32608 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson 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 | 2012-08-30 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086326 | K122646 | 000 |
| 00884838086302 | K122646 | 000 |
| 00884838084414 | K122646 | 000 |
| 00884838084407 | K122646 | 000 |
| 00884838073173 | K122646 | 000 |
| 00884838073166 | K122646 | 000 |
| 00884838066861 | K122646 | 000 |
| 00884838065970 | K122646 | 000 |
| 00884838065963 | K122646 | 000 |