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OARtrac

FDA UDI

Class II (US FDA UDI)

by Radiadyne, L.l.c.

Identity

Trade Name
OARtrac FDA UDI
Generic Name
MOSFET radiation therapy dosimetry system FDA UDI
Device Name
OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system’s own proprietary dose management software. FDA UDI
Model / Reference
OT-CDU FDA UDI
Description
OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system’s own proprietary dose management software. FDA UDI

Identifiers

Catalog Number
OT-CDU FDA UDI
Primary DI / UDI-DI
00851546007080 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.

Cleared under the same submission

K141154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiadyne, L.l.c.

Sources (1)

  • FDA UDI 3a184f6f-9ff8-4456-a0b4-8cbbd3c07a21 36 fields · synced May 30, 2026