ProFound Detection (V4.0)
K-Number: K240417 · 2024-11-08
ApplicantIcad, Inc.
Decision Date2024-11-08
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ProFound Detection (V4.0) is a medical device manufactured by Icad, Inc.. It received FDA 510(k) clearance on 2024-11-08 under approval number K240417. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ProFound Detection (V4.0)?
ProFound Detection (V4.0) is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Icad, Inc.. The 510(k) number is K240417.
When was ProFound Detection (V4.0) approved by the FDA?
ProFound Detection (V4.0) received FDA 510(k) clearance on 2024-11-08, under approval number K240417.
What company makes ProFound Detection (V4.0)?
ProFound Detection (V4.0) is manufactured by Icad, Inc..
What is the FDA product code for ProFound Detection (V4.0)?
The FDA product code for ProFound Detection (V4.0) is QDQ.
Other Devices by Icad, Inc.
Related Devices (Code: QDQ)
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.