Submission Details
| 510(k) Number | K100836 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 24, 2010 |
| Decision Date | June 16, 2010 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
CLEARPOINT SYSTEM
Jun 2010
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K100836 is an FDA 510(k) clearance for the CLEARPOINT SYSTEM, a Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (Class II — Special Controls, product code ORR), submitted by Surgivision, Inc. (Washington, US). The FDA issued a Cleared decision on June 16, 2010, 84 days after receiving the submission on March 24, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 882.4560.
Device Classification
| 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. |
Manufacturer
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