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Catalyst+ SP003

by C-Rad Positioning AB 2 variants

Catalyst+ SP003 (HY-004) is a Class II device made by C-Rad Positioning AB, cleared under FDA 510(k) K200435 on 7 May 2020, registered in EUDAMED and listed in FDA GUDID since 16 Jul 2020 (UDI-DI 17350005280038), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

CE MDR CE MDD 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

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number17350005280038 UDI-DI Date16 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK200435 Date7 May 2020IssuedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K200435 decided 7 May 2020 Active
  • EUDAMED Active· +1 more in the status table
  • FDA GUDID UDI-DI 17350005280038 listed 16 Jul 2020 Listed

Recalls

2 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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K200435
  2. Listed FDA GUDID 17350005280038
  3. Recall initiated FDA recalls Z-1858-2025
  4. Recall initiated FDA recalls Z-1092-2026

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Catalyst+
Generic name
Laser patient positioning system
Model / Ref / Catalog
SP003, HY-004
Primary DI / UDI-DI
17350005280038
510(k) Number
FDA product code
IYE
GMDN term
Laser patient positioning system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laser patient positioning system

Cleared under the same submission (K200435)

Similar devices in this category

Other devices filed under Laser patient positioning system.

Other devices from C-Rad Positioning AB

See all devices from C-Rad Positioning AB →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)