The following data is part of a premarket notification filed by Surgivision, Inc. with the FDA for Clearpoint System.
| Device ID | K100836 |
| 510k Number | K100836 |
| Device Name: | CLEARPOINT SYSTEM |
| Classification | Neurological Stereotaxic Instrument, Real-time Intraoperative Mri |
| Applicant | SURGIVISION, INC. COLUMBIA SQUARE 555 THIRTEENTH ST, NW Washington, DC 20004 |
| Contact | John J Smith M.d., J.d. |
| Correspondent | John J Smith M.d., J.d. SURGIVISION, INC. COLUMBIA SQUARE 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 | 2010-03-24 |
| Decision Date | 2010-06-16 |
| Summary: | summary |