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CAS-One IR Software

by Cascination AG

Ref 20016

CAS-One IR Software (20016) is a medical device (EU MDR Class IIb; FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed; EMDN category surgical navigation instruments - medical device software) made by CAScination AG, registered in EUDAMED on 12 Dec 2025 (Basic UDI-DI 764016722300C1R001KB), cleared under FDA 510(k) K232022 on 13 Mar 2024 and listed in FDA GUDID since 7 Jun 2024 (UDI-DI 07616962000281), active as of 25 Oct 2026.

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

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232022

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764016722300C1R001KB Basic UDI-DI Date12 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07616962000281 UDI-DI Date7 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK232022 Date13 Mar 2024IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 764016722300C1R001KB registered 12 Dec 2025 Active
  • FDA 510(k) K232022 decided 13 Mar 2024 Active
  • FDA GUDID UDI-DI 07616962000281 listed 7 Jun 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K232022
  2. Listed FDA GUDID 07616962000281
  3. Registered EUDAMED 764016722300C1R001KB

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  • Withdrawn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

Generic name
Radiology picture archiving and communication system workstation
Model / Ref / Catalog
20016, 4.1
Primary DI / UDI-DI
07616962000281 EUDAMED
07616962000335 EUDAMED
07616962000236 EUDAMED
07616962000090 EUDAMED
07616962000250 GUDID
Basic UDI-DI
764016722300C1R001KB
Direct marketing DI
07616962000335
07616962000236
07616962000090
510(k) Number
FDA product code
JAK
EMDN code
Z12011492 Surgical navigation instruments - medical device software
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1750
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
20016
GUDID
4.1
Primary DI / UDI-DIEUDAMED
07616962000281
07616962000335
07616962000236
07616962000090
GUDID
07616962000250
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 07616962000281, 07616962000335, 07616962000236, 07616962000090; FDA GUDID lists 07616962000250), so their flags are not compared. 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
CH-MF-000009927
Authorised representative
CAScination Deutschland GmbH DE-AR-000008247

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from CAScination AG

See all devices from CAScination AG →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)