The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Clearpoint System.
| Device ID | K181195 |
| 510k Number | K181195 |
| Device Name: | ClearPoint System |
| Classification | Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Applicant | MRI Interventions, Inc. 5 Musick Irvine, CA 92618 |
| Contact | Pete Piferi |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | ORR |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-04 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08503590070764 | K181195 | 000 |
| 08503590070757 | K181195 | 000 |
| 00850359007768 | K181195 | 000 |
| 00850359007751 | K181195 | 000 |
| 00850359007003 | K181195 | 000 |