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MapRT couch markers

by Vision RT Limited

MapRT couch markers is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K243301 on 19 May 2025 and listed in FDA GUDID since 23 Dec 2025 (UDI-DI 05056190501099), 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) K243301

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 Number05056190501099 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK243301 Date19 May 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243301 decided 19 May 2025 Active
  • FDA GUDID UDI-DI 05056190501099 listed 23 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243301
  2. Listed FDA GUDID 05056190501099

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MapRT
Generic name
Radiological video camera patient positioning/tracking system
Model / reference
MapRT couch markers
Primary DI / UDI-DI
05056190501099
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 (K243301)

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)