The following data is part of a premarket notification filed by Sentinel Medical, Inc. with the FDA for Sentinelle Breast Mri Tabletop With 16 Channel Coil Array For Siemens 1.5/3t Mri Systems.
| Device ID | K112112 |
| 510k Number | K112112 |
| Device Name: | SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SENTINEL MEDICAL, INC. 555 RICHMOND STREET WEST SUITE 800 Toronto, CA M5v 3b1 |
| Contact | Joan Medley |
| Correspondent | Joan Medley SENTINEL MEDICAL, INC. 555 RICHMOND STREET WEST SUITE 800 Toronto, CA M5v 3b1 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2011-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838109872 | K112112 | 000 |
| 00884838109544 | K112112 | 000 |
| 00884838109537 | K112112 | 000 |
| 00884838109520 | K112112 | 000 |
| 00884838109513 | K112112 | 000 |
| 00884838109506 | K112112 | 000 |
| 00884838109490 | K112112 | 000 |
| 00884838109483 | K112112 | 000 |
| 00884838112155 | K112112 | 000 |
| 00884838112148 | K112112 | 000 |
| 00884838120013 | K112112 | 000 |
| 00884838120006 | K112112 | 000 |
| 00884838119994 | K112112 | 000 |
| 00884838119987 | K112112 | 000 |
| 00884838119925 | K112112 | 000 |
| 00884838119918 | K112112 | 000 |
| 00884838119901 | K112112 | 000 |
| 00884838119895 | K112112 | 000 |
| 00884838109599 | K112112 | 000 |
| 00884838109605 | K112112 | 000 |
| 00884838109612 | K112112 | 000 |
| 00884838109865 | K112112 | 000 |
| 00884838109858 | K112112 | 000 |
| 00884838109841 | K112112 | 000 |
| 00884838109797 | K112112 | 000 |
| 00884838109780 | K112112 | 000 |
| 00884838109773 | K112112 | 000 |
| 00884838109766 | K112112 | 000 |
| 00884838109759 | K112112 | 000 |
| 00884838109742 | K112112 | 000 |
| 00884838109735 | K112112 | 000 |
| 00884838109681 | K112112 | 000 |
| 00884838109674 | K112112 | 000 |
| 00884838109667 | K112112 | 000 |
| 00884838109650 | K112112 | 000 |
| 00884838109643 | K112112 | 000 |
| 00884838109636 | K112112 | 000 |
| 00884838109629 | K112112 | 000 |
| 00884838119888 | K112112 | 000 |