OARtrac System with Skin Sensors
FDA 510(k) clearance K150719 · decided 2015-06-16
Clearance details
- K-number
- K150719
- Device name
- OARtrac System with Skin Sensors
- Applicant
- Radiadyne, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-19
- Decision date
- 2015-06-16
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NZT
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PRO-DOSE System (K250083) | Nu-Rise, SA | 2025-10-01 |
| OARtrac System (K182395) | Radialdyne, LLC | 2019-03-22 |
| OARtrac System with Patient Specific Reusable Universal PSD Sensors (K162954) | Radiadyne, LLC | 2017-06-01 |
| OARTRAC SYSTEM (K141154) | Radiadyne | 2014-07-22 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K083035) | Sicel Technologies, Inc. | 2008-11-13 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K080004) | Sicel Technologies, Inc. | 2008-01-23 |
Recalls involving this device
No recalls on record reference this clearance.