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 the device name listed in this FDA 510(k) record. The listed applicant is Ibex Medical Analytics , Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) 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. The listed applicant is Ibex Medical Analytics , Ltd.. The 510(k) number is K241232.
When did Galen™ Second Read™ receive FDA 510(k) clearance?
Galen™ Second Read™ received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241232.
Who is the listed applicant for Galen™ Second Read™?
The FDA 510(k) record lists Ibex Medical Analytics , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Galen™ Second Read™?
The FDA product code for Galen™ Second Read™ is 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.