Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Regulation 882.4560
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ORR
| Company | 510(k)s | Recalls |
|---|---|---|
| Mri Interventions, Inc. | 2 | 0 |
| Surgi-Vision, Inc. | 1 | 0 |
| Surgivision, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 2, 2018 | K181195 | ClearPoint System Mri Interventions, Inc. | ORR |
| Oct 20, 2017 | K171257 | ClearPoint System Mri Interventions, Inc. | ORR |
| Jun 22, 2011 | K111073 | SURGIVISION INC. CLEARPOINT SYSTEM Surgi-Vision, Inc. | ORR |
| Jun 16, 2010 | K100836 | CLEARPOINT SYSTEM Surgivision, Inc. | ORR |
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