510(k) K162954
- Device
- OARtrac System With Patient Specific Reusable Universal PSD Sensors
- Applicant
- RADIADYNE, LLC
- 510(k) number
- K162954
- Product code
- NZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-01
- Date received
- 2016-10-24
- Regulation
- 892.5050
- Classification name
- Dosimeter, Ionizing Radiation, Implanted
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN K. ISHAM
- Address
- 10801 Hammerly Blvd. Suite 220 Houston TX US 77043 77043
Source Documents#
Other 510(k) Records For Product Code NZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250083 | PRO-DOSE System | Nu-Rise, SA | 2025-10-01 |
| K182395 | OARtrac System | Radialdyne, LLC | 2019-03-22 |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015-06-16 |
| K141154 | OARTRAC SYSTEM | Radiadyne | 2014-07-22 |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-11-13 |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-01-23 |
Legacy Summary#
summary
FDA Review#
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