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RayStation 2024A SP3

by RaySearch Laboratories AB (PUBL)

Part of a family of 11 devices: see the family page

Ref 15.1

RayStation 2024A SP3 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 4 Aug 2026 (Basic UDI-DI 73500020101H8), cleared under FDA 510(k) K240398 on 4 Apr 2025 and listed in FDA GUDID since 10 Apr 2025 (UDI-DI 07350002010884), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

27 Sep 2031

CE MDR certificate

FDA recalls

2 ongoing

This device is named in the recall

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K240398

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/MDR EUDAMED Number73500020101H8 Basic UDI-DI Date4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010884 UDI-DI Date10 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240398 Date4 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 73500020101H8 registered 4 Aug 2026 Active
  • FDA 510(k) K240398 decided 4 Apr 2025 Active
  • FDA GUDID UDI-DI 07350002010884 listed 10 Apr 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 28620117938-05 Active Supplemented

    Quality management system EU MDR

    Certifier
    Intertek Medical Notified Body AB 2862
    Issued
    28 Sep 2026
    Expires
    27 Sep 2031
    Reason
    Add device or group

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1106-2026 FDA Class II initiated 28 Nov 2025

    Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

    • Ongoing Z-2495-2025 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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K240398
  2. Listed FDA GUDID 07350002010884
  3. Recall initiated FDA recalls Z-2495-2025
  4. Recall initiated FDA recalls Z-1106-2026
  5. Registered EUDAMED 73500020101H8

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
RayStation 2024A SP3 EUDAMED
RayStation 2024A SPC2 EUDAMED
RayStation GUDID
Generic name
Radiation therapy software
Model / reference
15.1 EUDAMED
2024A SP3 GUDID
Primary DI / UDI-DI
07350002010884, 07350002010846
Basic UDI-DI
73500020101H8
Direct marketing DI
07350002010884
07350002010846
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
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
15.1
GUDID
2024A SP3
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 (23, all answered No)