K241981
- 510(k) number
- K241981
- Device name
- Change Healthcare Stratus Imaging PACS
- Applicant
- Change Healthcare Canada Company CA
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-11-12
- Date received
- 2024-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K241981.pdf
Official FDA record: K241981
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.