Radiology · 510(k) · 2024
AISAP Cardio V1.0
Aisap. Cleared by FDA on 1 August 2024 under submission K234141, product code POK (computer-assisted diagnostic software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K234141
- Device. AISAP Cardio V1.0DEVICE
- Company. Aisap (IL)COMPANY
- Decision. 1 August 2024, 510(k), substantially equivalent (traditional review); received 29 December 2023DECISION
- 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 (12 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.
AISAP CARDIO V1.0 is a software platform that automatically processes and analyzes acquired cardiac POCUS images, producing a report with diagnostic assessment and measurements of several key cardiac structural and functional parameters, including: presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves and aortic stenosis), and measurements of the Left Ventricle Ejection Fraction (LVEF), right and left ventricular dimensions, right ventricular frac tional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter. The device outputs are provided in a report that is intended to support qualified physicians in their analysis and interpretation of adult cardiac POCUS images, using FDA-cleared ultrasound devices. Physicians should be trained and privileged by their organization following education processes and should perform cardiac POCUS according to their specialty professional society clinical guidelines. AISAP CARDIO V1.0 has not been validated for the assessment of congenital heart disease, and/or intra-cardiac lesions (e.g., tumors, thrombi, vegetations), prosthetic valves, and in the presence of ventricular assist devices. AISAP CARDIO V1.0 is indicated for use in adult patients only. The proposed device and both the Echo Go Pro v1.0.2 (primary predicate, K201555), and Echo Go Core 2.0 (secondary predicate, K213275) share the same general intended use, as adjunctive aids in the interpretation 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
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
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, or cleared in 2024. 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.