The following data is part of a premarket notification filed by Surgi-vision, Inc. with the FDA for Surgivision Inc. Clearpoint System.
| Device ID | K111073 |
| 510k Number | K111073 |
| Device Name: | SURGIVISION INC. CLEARPOINT SYSTEM |
| Classification | Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Applicant | SURGI-VISION, INC. 5 MUSICK Irvine, CA 92618 |
| Contact | Edward Waddell |
| Correspondent | Edward Waddell SURGI-VISION, INC. 5 MUSICK Irvine, CA 92618 |
| Product Code | ORR |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-06-22 |
| Summary: | summary |