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Vitesse 5.0

by Varian Medical Systems, Inc.

Ref Vitesse 5.0Model Vitesee

Vitesse 5.0 is a device classified as Class IIb in the EU and Class II in the US made by Varian Medical Systems, Inc., cleared under FDA 510(k) K241876 on 23 Oct 2024, registered in EUDAMED on 14 May 2024 (Basic UDI-DI 089947500201006PN) and listed in FDA GUDID since 1 Nov 2024 (UDI-DI 00850800006074), active as of 8 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241876

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850800006074 UDI-DI Date1 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241876 Date23 Oct 2024DecidedStatusActive
European UnionCE/MDR EUDAMED Number089947500201006PN Basic UDI-DI 00850800006074UDI-DIDate14 May 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K241876 decided 23 Oct 2024 Active
  • EUDAMED Basic UDI-DI 089947500201006PN registered 14 May 2024 Active
  • FDA GUDID UDI-DI 00850800006074 listed 1 Nov 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 089947500201006PN
  2. Cleared FDA 510(k) K241876
  3. Listed FDA GUDID 00850800006074

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  • Withdrawn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
Vitesse 5.0 EUDAMED
Vitesse GUDID
Generic name
Radiation therapy software
Model / Ref / Catalog
Vitesee, Vitesse 5.0, 5.0
Primary DI / UDI-DI
00850800006074
Basic UDI-DI
089947500201006PN
510(k) Number
FDA product code
MUJ
EMDN code
Z11010482 Radiotherapy treatment planning instruments - software accessories
GMDN term
Radiation therapy 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
Vitesee
Vitesse 5.0
GUDID
5.0
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.

Related devices

Category: Radiation therapy software

Similar devices in this category

Other devices filed under RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS.

Other devices from Varian Medical Systems, Inc.

See all devices from Varian Medical Systems, Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (23, all answered No)