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OARtrac ORB-60F

by Radiadyne, L.L.C.

OARtrac ORB-60F is a Class II device made by Radiadyne, L.L.C., cleared under FDA 510(k) K141154 on 22 Jul 2014 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00851546007066), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K141154

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851546007066 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141154 Date22 Jul 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141154 decided 22 Jul 2014 Active
  • FDA GUDID UDI-DI 00851546007066 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141154
  2. Listed FDA GUDID 00851546007066

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OARtrac
Generic name
Linear accelerator system
Model / Ref / Catalog
ORB-60F
Description
OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle
Primary DI / UDI-DI
00851546007066
510(k) Number
FDA product code
NZT, PCT
GMDN term
Linear accelerator system
Device class
Class II
Regulation number
892.5050, 892.5720
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Linear accelerator system

Cleared under the same submission (K141154)

Other devices from Radiadyne, L.L.C.

See all devices from Radiadyne, L.L.C. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)