510(k) K201019
K201019 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Genius AI Detection". The FDA issued a decision of Substantially Equivalent on Nov 18, 2020. The device falls under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2090. Hologic, Inc. has 119 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2020
- Date Received
- Apr 17, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2090
- Review Panel
- RA
- Submission Type
- 510(k)
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.