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RayStation 8.0

by RaySearch Laboratories AB (PUBL)

Ref 8.0

RayStation 8.0 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 27 Oct 2026 (Basic UDI-DI B-07350002010112), cleared under FDA 510(k) K180379 on 25 Apr 2018 and listed in FDA GUDID since 27 Jun 2018 (UDI-DI 07350002010112), active as of 7 Nov 2026. 7 FDA recalls are 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

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180379

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-07350002010112 Basic UDI-DI 07350002010112UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010112 UDI-DI Date27 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180379 Date25 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07350002010112 registered 27 Oct 2026 Active
  • FDA 510(k) K180379 decided 25 Apr 2018 Active
  • FDA GUDID UDI-DI 07350002010112 listed 27 Jun 2018 Listed

Recalls

7 recalls · 3 ongoing · FDA

    • Ongoing Z-2487-2025 FDA Class II initiated 8 Aug 2025

    DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

    • Ongoing Z-1185-2025 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.

    • Ongoing Z-1742-2024 FDA Class II initiated 28 Mar 2024

    Potential for reported SSD to be too high.

    • Terminated Z-0679-2019 FDA Class II initiated 12 Nov 2018

    Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.

    • Terminated Z-0294-2019 FDA Class II initiated 21 Sep 2018

    Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.

    • Terminated Z-2497-2018 FDA Class II initiated 29 Jun 2018

    If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.

    • Terminated Z-2554-2018 FDA Class II initiated 6 Jun 2018

    The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.

Timeline

10 dated events

  1. Cleared FDA 510(k) K180379
  2. Recall initiated FDA recalls Z-2554-2018
  3. Listed FDA GUDID 07350002010112
  4. Recall initiated FDA recalls Z-2497-2018
  5. Recall initiated FDA recalls Z-0294-2019
  6. Recall initiated FDA recalls Z-0679-2019
  7. Recall initiated FDA recalls Z-1742-2024
  8. Recall initiated FDA recalls Z-1185-2025
  9. Recall initiated FDA recalls Z-2487-2025
  10. Registered EUDAMED B-07350002010112

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 8.0 EUDAMED
RayStation GUDID
Generic name
Radiation therapy software
Model / reference
8.0
Primary DI / UDI-DI
07350002010112
Basic UDI-DI
B-07350002010112
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
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

Cleared under the same submission (K180379)

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)