← DeviceClear
HomeDevice Clearances

ProFound AI Software V2.1 — Icad, Inc. (510(k) K191994)

ProFound AI Software V2.1 — Icad, Inc. (510(k) K191994) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ProFound AI Software V2.1; Applicant: Icad, Inc.; Clearance track: 510(k).

Device nameProFound AI Software V2.1
ApplicantIcad, Inc.
Clearance track510(k)
Submission numberK191994
DecisionSubstantially Equivalent
Decision date2019-10-04
Date received2019-07-26
Product codeQDQ
Device class2
Medical specialtyRadiology
Applicant locationNH, US
SourceopenFDA device

🔍 Search all device clearances →