The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Sentinelle Endo Coil Array For Pelvic Imaging.
| Device ID | K103274 |
| 510k Number | K103274 |
| Device Name: | SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 Toronto, Ontario, CA M5v 3b1 |
| Contact | Cameron Piron |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083813 | K103274 | 000 |
| 00884838083806 | K103274 | 000 |
| 00884838081710 | K103274 | 000 |
| 00884838081628 | K103274 | 000 |
| 00884838081611 | K103274 | 000 |