The following data is part of a premarket notification filed by Invivo Corporation (business Trade Name: Philips) with the FDA for Ds Sentinelle Breast 16ch 3.0t Coil.
| Device ID | K213727 |
| 510k Number | K213727 |
| Device Name: | DS Sentinelle Breast 16ch 3.0T Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Invivo Corporation (Business Trade Name: Philips) 3545 SW 47th Ave Gainesville, FL 32608 |
| Contact | Ann Lebar |
| Correspondent | Jennifer Conyac Invivo Corporation (Business Trade Name: Philips) 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 | 2021-11-26 |
| Decision Date | 2022-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838105300 | K213727 | 000 |
| 00884838105331 | K213727 | 000 |
| 00884838105232 | K213727 | 000 |
| 00884838105225 | K213727 | 000 |
| 00884838105218 | K213727 | 000 |
| 00884838105201 | K213727 | 000 |
| 00884838105195 | K213727 | 000 |
| 00884838115514 | K213727 | 000 |