Digital Color Doppler Ultrasound System (P60 Series)
K-Number: K241949 · 2025-01-17
ApplicantSonoscape Medical Corp.
Decision Date2025-01-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Digital Color Doppler Ultrasound System (P60 Series) is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2025-01-17 under approval number K241949. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Digital Color Doppler Ultrasound System (P60 Series)?
Digital Color Doppler Ultrasound System (P60 Series) is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K241949.
When was Digital Color Doppler Ultrasound System (P60 Series) approved by the FDA?
Digital Color Doppler Ultrasound System (P60 Series) received FDA 510(k) clearance on 2025-01-17, under approval number K241949.
What company makes Digital Color Doppler Ultrasound System (P60 Series)?
Digital Color Doppler Ultrasound System (P60 Series) is manufactured by Sonoscape Medical Corp..
What is the FDA product code for Digital Color Doppler Ultrasound System (P60 Series)?
The FDA product code for Digital Color Doppler Ultrasound System (P60 Series) is IYN.
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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.