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Gatect-Rt

by Vision RT Limited

510(k) K072171

Gatect-Rt is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K072171 on 1 Oct 2007, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072171 Date1 Oct 2007ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
IYE
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K072171

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K072171
UDI-DISize and differences
AlignRT GATECT-RT 1.0
Vision RT Limited
GATECT-RT 1.005056190501365 —On the market

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 →