Galen Second Read
K-Number: K241232 · 2025-01-24
ApplicantIbex Medical Analytics , Ltd.
Decision Date2025-01-24
Product CodeQPN
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
Galen Second Read is a medical device manufactured by Ibex Medical Analytics , Ltd.. It received FDA 510(k) clearance on 2025-01-24 under approval number K241232. The device is classified under product code QPN. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Galen Second Read?
Galen Second Read is a medical device that received FDA 510(k) clearance on 2025-01-24. It is manufactured by Ibex Medical Analytics , Ltd.. The 510(k) number is K241232.
When was Galen Second Read approved by the FDA?
Galen Second Read received FDA 510(k) clearance on 2025-01-24, under approval number K241232.
What company makes Galen Second Read?
Galen Second Read is manufactured by Ibex Medical Analytics , Ltd..
What is the FDA product code for Galen Second Read?
The FDA product code for Galen Second Read is QPN.
Related Devices (Code: QPN)
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.