Radiology · 510(k) · 2020
EchoGo Pro
Ultromics Ltd. Cleared by FDA on 18 December 2020 under submission K201555, product code POK (computer-assisted diagnostic software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K201555
- Device. EchoGo ProDEVICE
- Company. Ultromics Ltd (GB)COMPANY
- Decision. 18 December 2020, 510(k), substantially equivalent (traditional review); received 10 June 2020DECISION
- 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 (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.
EchoGo Pro v1.0.2 is a machine lear ning-based decision support system, indicated as an adjunct to diagnostic stress echo cardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, 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 EchoGo Pro v1.0.2 analysis. Ec hoGo Pro v1.0.2 is to be used with stress echo exam protocols th at contain A2C, A4C and mid-ventricular short-axis views at rest and at peak stress. EchoGo Pro vl.0.2 is not intended for the assessment of mild or moderate myocardial ischemia, or localization of corona ry artery disease, or for the assessment of myocardial perfusion, myocardial viability or valve disease.
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.
- 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 Ultromics Ltd, 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.