# DEN190040: Caption Guidance

- Pathway: De Novo (Direct)
- Applicant: Bay Labs, Inc.
- Decided: Feb 7, 2020 after 164 days
- Product code: QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence)
- Device class: 2
- Regulation: 21 CFR 892.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200755: Caption Guidance (2020), 2 descendants of its own
- K242807: HeartFocus (V.1.1.1) (2025), 1 descendant of its own
- K201992: Caption Guidance (2020), 1 descendant of its own
- K260338: ThinkSono Guidance (2026), 0 descendants of its own
- K260780: HeartFocus (2026), 0 descendants of its own

## Indications for use
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, 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 (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

Source page: https://510kreport.com/device/DEN190040
Methodology: https://510kreport.com/methodology