The following data is part of a premarket notification filed by Radiadyne, Llc with the FDA for Oartrac System With Patient Specific Reusable Universal Psd Sensors.
| Device ID | K162954 |
| 510k Number | K162954 |
| Device Name: | OARtrac System With Patient Specific Reusable Universal PSD Sensors |
| Classification | Dosimeter, Ionizing Radiation, Implanted |
| Applicant | RADIADYNE, LLC 10801 HAMMERLY BLVD., SUITE 220 Houston, TX 77043 |
| Contact | John K. Isham |
| Correspondent | Stuart R. Goldman EMERGO GROUP 2500 BEE CAVE ROAD, BLDG. 1, SUITE 300 Austin, TX 78746 |
| Product Code | NZT |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-06-01 |
| Summary: | summary |