Identity
- Trade Name
- OARtrac FDA UDI
- Generic Name
- MOSFET radiation therapy dosimetry system FDA UDI
- Device Name
- OARtrac Proprietary System Software for CDU FDA UDI
- Model / Reference
- OT-PSS FDA UDI
- Description
- OARtrac Proprietary System Software for CDU FDA UDI
Identifiers
- Catalog Number
- OT-PSS FDA UDI
- Primary DI / UDI-DI
- 00851546007097 FDA UDI
- 510(k) Number
- K141154 FDA UDI
- FDA Product Code
- NZT FDA UDI
- GMDN Term
- MOSFET radiation therapy dosimetry system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MOSFET radiation therapy dosimetry system
OARtrac by Radiadyne, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MOSFET radiation therapy dosimetry system.
- mobileMOSFET — Best Medical Canada , Ltd. · Class II
- LANDAUER — Landauer · Class II
- Portable — Best Medical Canada , Ltd. · Class II
- OARtrac — RADIADYNE, L.L.C. · Class II
- OARtrac — RADIADYNE, L.L.C. · Class II
Cleared under the same submission
K141154 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Radiadyne, L.l.c.
Sources (1)
- FDA UDI dd06a313-147c-497b-95c4-2778b99be0ec 36 fields · synced May 30, 2026