The following data is part of a premarket notification filed by Radiadyne, Llc with the FDA for Oartrac System With Skin Sensors.
| Device ID | K150719 |
| 510k Number | K150719 |
| Device Name: | OARtrac System With Skin Sensors |
| Classification | Dosimeter, Ionizing Radiation, Implanted |
| Applicant | RadiaDyne, LLC 2313 W. Sam Houston Pkwy. N., Suite 107 Houston, TX 77043 |
| Contact | John K. Isham |
| Correspondent | Stuart R. Goldman EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austn, TX 78701 |
| Product Code | NZT |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-19 |
| Decision Date | 2015-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20851546007077 | K150719 | 000 |