Change Healthcare Stratus Imaging PACS
K-Number: K241981 · 2024-11-12
ApplicantChange Healthcare Canada Company
Decision Date2024-11-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Change Healthcare Stratus Imaging PACS is a medical device manufactured by Change Healthcare Canada Company. It received FDA 510(k) clearance on 2024-11-12 under approval number K241981. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Change Healthcare Stratus Imaging PACS?
Change Healthcare Stratus Imaging PACS is a medical device that received FDA 510(k) clearance on 2024-11-12. It is manufactured by Change Healthcare Canada Company. The 510(k) number is K241981.
When was Change Healthcare Stratus Imaging PACS approved by the FDA?
Change Healthcare Stratus Imaging PACS received FDA 510(k) clearance on 2024-11-12, under approval number K241981.
What company makes Change Healthcare Stratus Imaging PACS?
Change Healthcare Stratus Imaging PACS is manufactured by Change Healthcare Canada Company.
What is the FDA product code for Change Healthcare Stratus Imaging PACS?
The FDA product code for Change Healthcare Stratus Imaging PACS is LLZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.