Radiology · 510(k) · 2020
Genius AI Detection
Hologic, Inc.. Cleared by FDA on 18 November 2020 under submission K201019, product code QDQ (radiological computer assisted detection/diagnosis software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K201019
- Device. Genius AI DetectionDEVICE
- Company. Hologic, Inc.COMPANY
- Decision. 18 November 2020, 510(k), substantially equivalent (traditional review); received 17 April 2020DECISION
- Panel. RadiologyPANEL
- Product code. QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in DBT exams from compatib le DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam. Standards: • IEC 62304: 2015 – Medical device software – Software Life Cycle Processes (#13-79) • ISO 14971: 2012 – Medical devices – Application of Risk Management to Medical Devices • DEN180005 Evaluation of automatic class III designation for OsteoDetect – Decision summary with special controls. FDA Guidance Documents: • Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued on May 11, 2005) • Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions (Issued on July 3, 2012) • Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - […]
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QDQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDQ, in Radiology, from Hologic, Inc., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.