K181195 is an FDA 510(k) clearance for the ClearPoint System. This device is classified as a Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (Class II - Special Controls, product code ORR).
Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on November 2, 2018, 182 days after receiving the submission on May 4, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560. To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite..
| 510(k) Number | K181195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2018 |
| Decision Date | November 02, 2018 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ORR - Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite. |