UniSyn Molecular Imaging (6-3-1)
K-Number: K231047 · 2023-09-01
ApplicantConvergent Imaging Solutions
Decision Date2023-09-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UniSyn Molecular Imaging (6-3-1) is a medical device manufactured by Convergent Imaging Solutions. It received FDA 510(k) clearance on 2023-09-01 under approval number K231047. 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 UniSyn Molecular Imaging (6-3-1)?
UniSyn Molecular Imaging (6-3-1) is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Convergent Imaging Solutions. The 510(k) number is K231047.
When was UniSyn Molecular Imaging (6-3-1) approved by the FDA?
UniSyn Molecular Imaging (6-3-1) received FDA 510(k) clearance on 2023-09-01, under approval number K231047.
What company makes UniSyn Molecular Imaging (6-3-1)?
UniSyn Molecular Imaging (6-3-1) is manufactured by Convergent Imaging Solutions.
What is the FDA product code for UniSyn Molecular Imaging (6-3-1)?
The FDA product code for UniSyn Molecular Imaging (6-3-1) 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.