The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Optical Tracking System (ots).
| Device ID | K964801 |
| 510k Number | K964801 |
| Device Name: | OPTICAL TRACKING SYSTEM (OTS) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Contact | Amy J Laforte, Ph.d. |
| Correspondent | Amy J Laforte, Ph.d. RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-06-02 |
| Summary: | summary |