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RTgo

by Philips Medical Systems Nederland B.V. 2 variants

Ref 300011392021

RTgo (300011392021) is a device classified as Class IIb in the EU and Class II in the US made by Philips Medical Systems Nederland B.V., registered in EUDAMED on 18 Apr 2025 (Basic UDI-DI 0884838BM953TU) with CE/MDR certificate 2243595CE01 valid until 1 May 2030, cleared under FDA 510(k) K214081 on 5 Apr 2022 and listed in FDA GUDID since 20 Jun 2024 (UDI-DI 00884838122123), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

1 May 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K214081

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243595CE01 Date24 Sep 2026IssuedStatusActive expires 1 May 2030
United StatesGUDID listing GUDID Number00884838122123 UDI-DI Date20 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK214081 Date5 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0884838BM953TU registered 18 Apr 2025 Active· +1 more in the status table
  • FDA 510(k) K214081 decided 5 Apr 2022 Active
  • FDA GUDID UDI-DI 00884838122123 listed 20 Jun 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    24 Sep 2026
    Expires
    1 May 2030
    Reason
    Add device or group

Timeline

5 dated events

  1. Cleared FDA 510(k) K214081
  2. Listed FDA GUDID 00884838122123
  3. Registered EUDAMED 0884838BM953TU
  4. Certificate issued EUDAMED 2243595CE01
  5. Certificate expires EUDAMED 2243595CE01

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
RTgo EUDAMED
MR-Rt GUDID
Generic name
MRI system application software
Device name
Ingenia MR-RT software
Model / Ref / Catalog
300011392021, RTgo
Primary DI / UDI-DI
00884838122123
Basic UDI-DI
0884838BM953TU
Direct marketing DI
00884838122123
FDA product code
MUJ
EMDN code
Z11050192 Magnetic resonance (MR) systems - medical device software
GMDN term
MRI system application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
300011392021
GUDID
RTgo
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Similar devices in this category

Other devices filed under MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE.

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)