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AlignRT Plus Real Time Coach MK2

by Vision RT Limited

AlignRT Plus Real Time Coach MK2 is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K212583 on 10 Nov 2021 and listed in FDA GUDID since 23 Dec 2025 (UDI-DI 05056190501037), 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) K212583

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 Number05056190501037 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK212583 Date10 Nov 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212583 decided 10 Nov 2021 Active
  • FDA GUDID UDI-DI 05056190501037 listed 23 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212583
  2. Listed FDA GUDID 05056190501037

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  • Withdrawn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
Real Time Coach MK2
Primary DI / UDI-DI
05056190501037
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

Related devices

Cleared under the same submission (K212583)

and 1 more cleared under K212583

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)