FDA 510(k) clearance · back to tracker

Change Healthcare Stratus Imaging PACS

Change Healthcare Canada Company cleared K241981 on 2024-11-12, decision: substantially equivalent

K-number

K241981

Sponsor

Change Healthcare Canada Company

Device

Change Healthcare Stratus Imaging PACS

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-11-12

Product code

LLZ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2050

Official FDA record

Open K241981on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K241981 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.