Radiology · 510(k) · 2025
HeartFocus (V.1.1.1)
Deski. Cleared by FDA on 4 April 2025 under submission K242807, product code QJU (image acquisition and/or optimization guided by artificial intelligence). What FDA's record says, in FDA's words.
Device record · K242807
- Device. HeartFocus (V.1.1.1)DEVICE
- Company. Deski (FR)COMPANY
- Decision. 4 April 2025, 510(k), substantially equivalent (traditional review); received 17 September 2024DECISION
- Panel. RadiologyPANEL
- Product code. QJU, Image Acquisition And/Or Optimization Guided By Artificial IntelligenceCODE
- Regulation. 21 CFR 892.2100, Class IIREG
- Source. FDA database entry · decision document (24 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.
The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). Specifically, in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4- Chamber (SC-4C), and Subcostal inferior Vena Cava (SC-IVC). HeartFocus software is indicated for use in adult patients who require a cardiac ultrasound exam.
The product code's definition, from FDA's classification record. A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.
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
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QJU. 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 QJU, in Radiology, from Deski, or cleared in 2025. 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.