Change Healthcare Stratus Imaging PACS
FDA 510(k) K241981 · Change Healthcare Canada Company
510(k) numberK241981
Submission
- Device name
- Change Healthcare Stratus Imaging PACS
- Applicant
- Change Healthcare Canada Company
Richmond, CA - Received
- July 5, 2024
- Decision date
- November 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Change Healthcare Stratus Imaging PACS cleared by the FDA?
Change Healthcare Stratus Imaging PACS (K241981) received a 510(k) decision of Substantially Equivalent on November 12, 2024, 130 days after the submission was received.
What is the product code of K241981?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.