Skip to content

Change Healthcare Stratus Imaging Viewer 1.0.25

by Change Healthcare Canada Company

Ref 1.0.25

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-17540262140262 Basic UDI-DI 17540262140262UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17540262140262 UDI-DI Date16 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1773-2021 FDA Class II initiated 19 Apr 2021

    A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

    • Ongoing Z-1508-2021 FDA Class II initiated 17 Mar 2021

    Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Change Healthcare Stratus Imaging Viewer
Generic Name
Radiological PACS-dedicated management software
Model / Reference
1.0.25
Primary DI / UDI-DI
17540262140262
Basic UDI-DI
B-17540262140262
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
-1192
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K181185)

Other devices from Change Healthcare Canada Company

See all devices from Change Healthcare Canada Company →

Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No