Transpara Density 1.0.0
K-Number: K232096 · 2023-12-11
ApplicantScreenpoint Medical B.V.
Decision Date2023-12-11
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Transpara Density 1.0.0 is a medical device manufactured by Screenpoint Medical B.V.. It received FDA 510(k) clearance on 2023-12-11 under approval number K232096. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Transpara Density 1.0.0?
Transpara Density 1.0.0 is a medical device that received FDA 510(k) clearance on 2023-12-11. It is manufactured by Screenpoint Medical B.V.. The 510(k) number is K232096.
When was Transpara Density 1.0.0 approved by the FDA?
Transpara Density 1.0.0 received FDA 510(k) clearance on 2023-12-11, under approval number K232096.
What company makes Transpara Density 1.0.0?
Transpara Density 1.0.0 is manufactured by Screenpoint Medical B.V..
What is the FDA product code for Transpara Density 1.0.0?
The FDA product code for Transpara Density 1.0.0 is QIH.
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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.