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RayCare 2024A SP1

by RaySearch Laboratories AB (PUBL)

Ref RayCare 8.0

RayCare 2024A SP1 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 73500020102HA), cleared under FDA 510(k) K242992 on 17 Apr 2025 and listed in FDA GUDID since 30 Apr 2025 (UDI-DI 07350002010839), 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

No date given

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242992

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 Number73500020102HA Basic UDI-DI Date4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07350002010839 UDI-DI Date30 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK242992 Date17 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 73500020102HA registered 4 Aug 2026 Active
  • FDA 510(k) K242992 decided 17 Apr 2025 Active
  • FDA GUDID UDI-DI 07350002010839 listed 30 Apr 2025 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2646-2026 FDA Class II initiated 20 May 2026
    • Ongoing Z-2647-2026 FDA Class II initiated 20 May 2026

    Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

Timeline

5 dated events

  1. Cleared FDA 510(k) K242992
  2. Listed FDA GUDID 07350002010839
  3. Recall initiated FDA recalls Z-2646-2026
  4. Recall initiated FDA recalls Z-2647-2026
  5. Registered EUDAMED 73500020102HA

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
RayCare 2024A SP3 EUDAMED
RayCare 2024A SP1 EUDAMED
RayCare 2024A EUDAMED
RayCare GUDID
Generic name
Radiology information system application software
Model / reference
RayCare 8.0 EUDAMED
2024A SP1 GUDID
Primary DI / UDI-DI
07350002010839, 07350002010877, 07350002010792
Basic UDI-DI
73500020102HA
Direct marketing DI
07350002010877
07350002010839
07350002010792
510(k) Number
FDA product code
MUJ
EMDN code
Z11019082 Various radiotherapy and radiosurgery instruments - software accessories
GMDN term
Radiology information system application 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
RayCare 8.0
GUDID
2024A SP1
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: Radiology information system application software

Cleared under the same submission (K242992)

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)