OARTRAC SYSTEM
FDA 510(k) clearance K141154 · decided 2014-07-22
Clearance details
- K-number
- K141154
- Device name
- OARTRAC SYSTEM
- Applicant
- Radiadyne
- Decision
- Substantially Equivalent
- Date received
- 2014-05-05
- Decision date
- 2014-07-22
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- NZT
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiadyne
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 with Skin Sensors (K150719) | Radiadyne, LLC | 2015-06-16 |
| 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.