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Catalyst+

by C-RAD Positioning AB

Ref SP003-0001Model Catalyst+

Catalyst+ (SP003-0001) is a device classified as Class IIb in the EU and Class II in the US made by C-Rad Positioning Ab, registered in EUDAMED on 13 Feb 2024 (Basic UDI-DI 735000528Catalyst+ZU), cleared under FDA 510(k) K200435 on 7 May 2020 (1 earlier submission) and listed in FDA GUDID since 6 Aug 2024 (UDI-DI 17350005280762), active as of 24 Oct 2026. 3 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) K200435

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number17350005280762 UDI-DI Date6 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number735000528Catalyst+ZU Basic UDI-DI 17350005280762UDI-DIDate13 Feb 2024RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK200435 Date7 May 2020IssuedStatusActive
United StatesFDA 510(k) 510(k) NumberK113276 Date27 Feb 2012IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 735000528Catalyst+ZU registered 13 Feb 2024 Active
  • FDA 510(k) K200435 decided 7 May 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 17350005280762 listed 6 Aug 2024 Listed

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-1092-2026 FDA Class II initiated 9 Oct 2025

    Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.

    • Ongoing Z-1858-2025 FDA Class II initiated 22 Apr 2025

    Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

    • Terminated Z-2075-2021 FDA Class II initiated 6 Aug 2020

    PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

Timeline

7 dated events

  1. Cleared FDA 510(k) K113276
  2. Cleared FDA 510(k) K200435
  3. Recall initiated FDA recalls Z-2075-2021
  4. Registered EUDAMED 735000528Catalyst+ZU
  5. Listed FDA GUDID 17350005280762
  6. Recall initiated FDA recalls Z-1858-2025
  7. Recall initiated FDA recalls Z-1092-2026

Coverage

2 jurisdictions

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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Laser patient positioning system
Model / reference
Catalyst+, SP003-0001
Primary DI / UDI-DI
17350005280762
Basic UDI-DI
735000528Catalyst+ZU, B-17350005280762
Direct marketing DI
17350005280762
510(k) Number
FDA product code
IYE
EMDN code
Z119010 Laser systems for patient positioning
GMDN term
Laser patient positioning system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Sweden
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.

Manufacturer details

EUDAMED SRN
SE-MF-000022326

Related devices

Category: Laser patient positioning system

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from C-Rad Positioning Ab

See all devices from C-Rad Positioning Ab →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)