The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Optical Tracking System With Surface Matching Module, Model Ots.
| Device ID | K983669 |
| 510k Number | K983669 |
| Device Name: | OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | David Cromwick |
| Correspondent | David Cromwick RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1998-11-18 |
| Summary: | summary |