# K260338: ThinkSono Guidance

- Pathway: 510(k) (Traditional)
- Applicant: ThinkSono GmbH
- Decided: Jul 15, 2026 after 163 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
Longest line of descent: 1 generation back to DEN190040 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190040: Caption Guidance, Bay Labs, Inc. (2020) Summary page 5.

## Indications for use
The ThinkSono Guidance software is intended to assist non-ultrasound-trained healthcare professionals in the acquisition of vascular ultrasound images by providing real-time guidance during probe positioning and image acquisition. The software is compatible with point-of-care diagnostic ultrasound systems. ThinkSono Guidance does not assist in interpretation of ultrasound images. ThinkSono Guidance is indicated for adult patients who require a lower extremity compression ultrasound exam for the evaluation of suspected deep vein thrombosis (DVT).

Source page: https://510kreport.com/device/K260338
Methodology: https://510kreport.com/methodology