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MR-RT MRCAT Brain / RTgo 4.0

by Philips Oy

MR-RT MRCAT Brain / RTgo 4.0 (781439) is a Class II device made by Philips Oy, cleared under FDA 510(k) K193109 on 24 Jan 2020 and listed in FDA GUDID since 26 Apr 2022 (UDI-DI 00884838094093), active as of 23 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 23 Oct 2026

Documents

510(k) K193109

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838094093 UDI-DI Date26 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193109 Date24 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193109 decided 24 Jan 2020 Active
  • FDA GUDID UDI-DI 00884838094093 listed 26 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193109
  2. Listed FDA GUDID 00884838094093

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MR-Rt
Generic name
MRI system application software
Model / Ref / Catalog
MRCAT Brain / RTgo 4.0, 781439
Primary DI / UDI-DI
00884838094093
FDA product code
MUJ
GMDN term
MRI system application software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system application software

Cleared under the same submission (K193109)

Similar devices in this category

Other devices filed under MRI system application software.

Other devices from Philips Oy

See all devices from Philips Oy →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)