AI devices with FDA product code DQK — Computer, Diagnostic, Programmable
Product code DQK (“Computer, Diagnostic, Programmable” in openFDA) covers 28 devices on the FDA AI-enabled list, from 13 companies. Most are reviewed by the Cardiovascular panel (28). The most recent decision was ZEUS Platform (FG0501US) on May 29, 2026.
28AI devices
13Companies
2018First decision
2026-05-29Latest decision
Trend: devices per year
201820192020202120222023202420252026
Top companies
All 28 devices, newest first
- ZEUS Platform (FG0501US)iRhythm Technologies, Inc. · Cardiovascular
- CARTO 3 EP Navigation System V8.4Biosense Webster, Inc. · Cardiovascular
- SafeBeat Rx AppSafeBeat Rx, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- Volta AF-Xplorer IIVolta Medical · Cardiovascular
- PhysCade SystemPhysCade, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- Volta AF-XplorerVolta Medical · Cardiovascular
- VitalRhythmVitalConnect, Inc. · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- HeartKey® RhythmB-Secur Limited · Cardiovascular
- Volta AF-XplorerVolta Medical · Cardiovascular
- CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. · Cardiovascular
- ZEUS SystemiRhythm Technologies, Inc. · Cardiovascular
- VX1+Volta Medical · Cardiovascular
- STAR Apollo Mapping SystemRhythm Al, Ltd · Cardiovascular
- DeepRhythmAIMedicalgorithmics S.A. · Cardiovascular
- ZEUS System (Zio Watch)iRhythm Technologies, Inc. · Cardiovascular
- AliveCor QT ServiceAliveCor, Inc. · Cardiovascular
- IM007Implicity, Inc. · Cardiovascular
- Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc. · Cardiovascular
- KardiaAIAliveCor, Inc. · Cardiovascular
- VX1Volta Medical · Cardiovascular
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · Cardiovascular
- KardiaAIAliveCor, Inc. · Cardiovascular
- RhythmAnalyticsBiofourmis Singapore Pte. Ltd. · Cardiovascular
- AI-ECG PlatformShenzhen Carewell Electronics., Ltd · Cardiovascular
- Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · Cardiovascular