OARtrac System
Dosimeter, Ionizing Radiation, Implanted
RadialDyne, LLC
The following data is part of a premarket notification filed by Radialdyne, Llc with the FDA for Oartrac System.
Pre-market Notification Details
| Device ID | K182395 |
| 510k Number | K182395 |
| Device Name: | OARtrac System |
| Classification | Dosimeter, Ionizing Radiation, Implanted |
| Applicant | RadialDyne, LLC 10801 Hammerly Blvd. Suite 220 Houston, TX 77043 |
| Contact | John Isham |
| Correspondent | Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bay Area Blvd., #30 Houston, TX 77058 |
| Product Code | NZT |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-03-22 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851546007196 | K182395 | 000 |
Trademark Results [OARtrac System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OARTRAC SYSTEM 85058933 not registered Dead/Abandoned |
Radiadyne, LLC 2010-06-09 |
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