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Change Healthcare Stratus Imaging Diagnostic Viewer 2.10

by Change Healthcare Canada Company

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17540262200102 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Change Healthcare Stratus Imaging Diagnostic Viewer
Generic Name
Radiological PACS-dedicated management software
Model / Reference
2.10
Primary DI / UDI-DI
17540262200102
510(k) Number
FDA Product Code
LLZ
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K240724)

Other devices from Change Healthcare Canada Company

See all devices from Change Healthcare Canada Company →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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