The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Sv Brain Array, Siemens 3t.
| Device ID | K111802 |
| 510k Number | K111802 |
| Device Name: | SV BRAIN ARRAY, SIEMENS 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | E.f. Waddell |
| Correspondent | E.f. Waddell MRI INTERVENTIONS, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850359007057 | K111802 | 000 |
| 08503590070573 | K111802 | 000 |
| 00850359007577 | K111802 | 000 |