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RayStation 6.0

by RaySearch Laboratories AB (PUBL)

Ref RayStation 6.0

RayStation 6.0 is a device classified as Class IIb in the EU and Class II in the US made by RaySearch Laboratories AB (PUBL), registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-07350002010013), cleared under FDA 510(k) K170355 on 2 Mar 2017 and listed in FDA GUDID since 12 Jul 2017 (UDI-DI 07350002010013), active as of 7 Nov 2026. One FDA recall is linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170355

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350002010013 Basic UDI-DI 07350002010013UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010013 UDI-DI Date12 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170355 Date2 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350002010013 registered 26 Oct 2026 Active
  • FDA 510(k) K170355 decided 2 Mar 2017 Active
  • FDA GUDID UDI-DI 07350002010013 listed 12 Jul 2017 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1193-2025 FDA Class II initiated 16 Jan 2025

    Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

Timeline

4 dated events

  1. Cleared FDA 510(k) K170355
  2. Listed FDA GUDID 07350002010013
  3. Recall initiated FDA recalls Z-1193-2025
  4. Registered EUDAMED B-07350002010013

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
RayStation
Generic name
Radiation therapy software
Device name
RayStation 6.0
Model / reference
RayStation 6.0 EUDAMED
6.0 GUDID
Primary DI / UDI-DI
07350002010013
Basic UDI-DI
B-07350002010013
510(k) Number
FDA product code
MUJ
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
GMDN term
Radiation therapy software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RayStation 6.0
GUDID
6.0
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 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

Other devices from RaySearch Laboratories AB (PUBL)

See all devices from RaySearch Laboratories AB (PUBL) →

Properties

  • Prescription use
  • Manufacturing date
Other properties (21, all answered No)