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RayStation 12A

by RaySearch Laboratories AB (PUBL)

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

Ref 13.0

RayStation 12A 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) with CE/MDR certificate 28620117938-05 valid until 27 Sep 2031, cleared under FDA 510(k) K222312 on 29 Mar 2023 and listed in FDA GUDID since 12 May 2023 (UDI-DI 07350002010549), active as of 23 Oct 2026. 6 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

6 ongoing

This device is named in the recall

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K222312

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number28620117938-05 Date28 Sep 2026IssuedStatusActive expires 27 Sep 2031
United StatesGUDID listing GUDID Number07350002010549 UDI-DI Date12 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222312 Date29 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 73500020101H8 registered 4 Aug 2026 Active· +1 more in the status table
  • FDA 510(k) K222312 decided 29 Mar 2023 Active
  • FDA GUDID UDI-DI 07350002010549 listed 12 May 2023 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

6 recalls · 6 ongoing · FDA

    • Ongoing Z-1105-2026 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-2493-2025 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-1191-2025 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.

  • 2 recalls, same reason

    • Ongoing Z-1750-2024 FDA Class II initiated 28 Mar 2024
    • Ongoing Z-1751-2024 FDA Class II initiated 28 Mar 2024

    Potential for reported SSD to be too high.

    • Ongoing Z-1482-2024 FDA Class II initiated 23 Feb 2024

    A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

Timeline

11 dated events

  1. Listed FDA GUDID 07350002010549
  2. Recall initiated FDA recalls Z-1482-2024
  3. Recall initiated FDA recalls Z-1750-2024
  4. Recall initiated FDA recalls Z-1751-2024
  5. Recall initiated FDA recalls Z-1191-2025
  6. Recall initiated FDA recalls Z-2493-2025
  7. Recall initiated FDA recalls Z-1105-2026
  8. Registered EUDAMED 73500020101H8
  9. Certificate issued EUDAMED 28620117938-05
  10. Certificate expires EUDAMED 28620117938-05

1 earlier event are in the sections above.

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 12A EUDAMED
RayStation GUDID
Generic name
Radiation therapy software
Model / reference
13.0 EUDAMED
12A GUDID
Primary DI / UDI-DI
07350002010549
Basic UDI-DI
73500020101H8
Direct marketing DI
07350002010549
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
13.0
GUDID
12A
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 (K222312)

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)