Radiology · 510(k) · 2019
Koios DS for Breast
Koios Medical, Inc.. Cleared by FDA on 3 July 2019 under submission K190442, product code POK (computer-assisted diagnostic software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K190442
- Device. Koios DS for BreastDEVICE
- Company. Koios Medical, Inc.COMPANY
- Decision. 3 July 2019, 510(k), substantially equivalent (traditional review); received 25 February 2019DECISION
- Panel. RadiologyPANEL
- Product code. POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2060, Class IIREG
- Source. FDA database entry · decision document (17 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.
Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination. Koios DS for Breast is a machine learning-based decision support system, indicated as an adjunct to diagnostic ultrasound for breast cancer. Koios DS for Breast automatically classifies user-selected region(s) of interest (ROIs) containing a breast lesion into four BI-RADS-aligned categories (Benign, Probably Benign, Suspicious, Probably Malignant), and displays a continuous graphical confidence level indicator of where the lesion falls across all categories. Koios DS for Breast also automatically classifies lesion shape and orientation according to BI-RADS descriptors. The software requires a user to select up to two ROIs, from up to two orthogonal views, that represent a single lesion to be selected and processed. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the Koios DS for Breast analysis. This device is intended to help trained interpreting physicians improve their overall accuracy as well as reduce inter- and intra-operator variability. Koios DS for Breast may also be used as an image viewer of […]
The product code's definition, from FDA's classification record. Assist users in characterizing lesions identified on acquired medical images
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.
- Modalities namedultrasound
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code POK. 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. The latest reports, in the reporter’s words:
15 January 2021 · Malfunction · QUANTX · report MW5098869
QUANTX SOFTWARE MAY ENTER INTO AN ERROR STATE IN WHICH MEDICAL IMAGES DISPLAYED TO THE USER ARE FROZEN IN PLACE. QUANTX SOFTWARE VERSION (B)(4) ENTER INTO AN ERROR STATE IN WHICH ONE VIEWPORT IS FROZEN IN PLACE. WHEN THIS ERROR OCCURS, QUANTX STOPS RESPONDING TO USER INPUTS TO MODIFY THE DISPLAY OF THE FROZEN IMAGE. THIS ERROR STATE IS REACHED THROUGH A SPECIFIC SEQUENCE OF KEYSTROKES AND MOUSE ACTIONS. ONCE THE ONE IMAGE IS FROZEN IN A VIEWPORT IT REMAINS FROZEN. IT WILL ALSO REMAIN FROZEN IF […]
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 POK, in Radiology, from Koios Medical, Inc., or cleared in 2019. 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.