# K191556: Red Dot

- Pathway: 510(k) (Traditional)
- Applicant: Behold.Ai Technologies Limited
- Decided: Feb 28, 2020 after 261 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN170073 (2018). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190362: HealthPNX, Zebra Medical Vision, Ltd. (2019) Summary page 4.

## Most influential descendants
- K213941: Annalise Enterprise CXR Triage Pneumothorax (2022), 3 descendants of its own
- K222179: Annalise Enterprise CXR Triage Trauma (2023), 1 descendant of its own
- K250831: Annalise Enterprise (2025), 0 descendants of its own
- K222268: Annalise Enterprise CXR Triage Trauma (2023), 0 descendants of its own
- K221552: EFAI ChestSuite XR Pneumothorax Assessment System (2022), 0 descendants of its own

## Indications for use
The red dot™ software platform is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. red dot™ analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. red dot™ is not intended to direct attention to specific portions of an image or to anomalies other than Pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.

Source page: https://510kreport.com/device/K191556
Methodology: https://510kreport.com/methodology