Radiology · 510(k) · 2021
MammoScreen 2.0
Therapixel. Cleared by FDA on 26 November 2021 under submission K211541, 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 · K211541
- Device. MammoScreen 2.0DEVICE
- Company. Therapixel (FR)COMPANY
- Decision. 26 November 2021, 510(k), substantially equivalent (traditional review); received 19 May 2021DECISION
- 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 (8 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.
MammoScreen is intended for use as a concurrent reading aid for interpreting physicians, to help identify findings on screening FFDM or DBT acquired with compatible mammography systems, and assess their level of suspicion. Output of the device includes marks placed on findings on the mammogram and level of suspicion sc ores. The findings could be soft tissue lesions or calcifications. The level of suspicion score is expressed at the finding level, for each breast and overall for the mammogram. Patient management decisions should not be made solely on the basis of analysis by MammoScreen. 510(k) submission MammoScreen 2.0
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.
- Mentionsdetection or identification of findings
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 Therapixel, or cleared in 2021. 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.