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AlignRT Plus AlignRT Offline

by Vision RT Limited

AlignRT Plus AlignRT Offline is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K203387 on 4 Mar 2021 and listed in FDA GUDID since 23 Sep 2021 (UDI-DI 05056190500030), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K203387

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 Number05056190500030 UDI-DI Date23 Sep 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) from GUDID NumberK203387 Date4 Mar 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203387 decided 4 Mar 2021 Active
  • FDA GUDID UDI-DI 05056190500030 listed 23 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203387
  2. Listed FDA GUDID 05056190500030

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AlignRT Plus
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
AlignRT Offline
Primary DI / UDI-DI
05056190500030
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
Not in Commercial Distribution

Related devices

Cleared under the same submission (K203387)

and 8 more cleared under K203387

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)