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AlignRT GATECT-RT 1.0

by Vision RT Limited

AlignRT GATECT-RT 1.0 is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K072171 on 1 Oct 2007 and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 05056190501365), 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) K072171

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 Number05056190501365 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072171 Date1 Oct 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072171 decided 1 Oct 2007 Active
  • FDA GUDID UDI-DI 05056190501365 listed 27 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072171
  2. Listed FDA GUDID 05056190501365

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AlignRT
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
GATECT-RT 1.0
Primary DI / UDI-DI
05056190501365
510(k) Number
FDA product code
IYE
GMDN term
Radiological video camera patient positioning/tracking system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Vision RT Limited

See all devices from Vision RT Limited →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)