28 devices · 13 companies · 2018 to 2026
Product code DQK: Computer, Diagnostic, Programmable
28 devices under product code DQK, 2018 to 2026, from 13 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (27 of 28 here), the regulation, and MAUDE report counts by product code.
Computer, Diagnostic, Programmable. 21 CFR 870.1425, Class II. MAUDE held 4,558 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| ZEUS PlatformK252859 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry | |
| CARTO 3 EP Navigation System V8.4K252972 · 510(k) | Biosense Webster, Inc. | Cardiovascular | database entry | |
| SafeBeat Rx AppK251218 · 510(k) | SafeBeat Rx, Inc. | Cardiovascular | database entry | |
| DeepRhythmAIK253141 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | database entry | |
| Volta AF-Xplorer IIK251518 · 510(k) | Volta Medical | Cardiovascular | database entry | |
| PhysCade SystemK250749 · 510(k) | PhysCade, Inc. | Cardiovascular | database entry | |
| DeepRhythmAIK250932 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | database entry | |
| Volta AF-XplorerK243812 · 510(k) | Volta Medical | Cardiovascular | database entry | |
| VitalRhythmK242129 · 510(k) | VitalConnect, Inc. | Cardiovascular | database entry | |
| DeepRhythmAIK241197 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | database entry | |
| HeartKey RhythmK233755 · 510(k) | B-Secur Limited | Cardiovascular | database entry | |
| Volta AF-XplorerK232616 · 510(k) | Volta Medical | Cardiovascular | database entry | |
| CARTO 3 EP Navigation System Software V8.0K231207 · 510(k) | Biosense Webster, Inc. | Cardiovascular | database entry | |
| ZEUS SystemK222389 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry | |
| VX1+K223516 · 510(k) | Volta Medical | Cardiovascular | database entry | |
| STAR Apollo Mapping SystemK220786 · 510(k) | Rhythm Al, Ltd | Cardiovascular | database entry | |
| DeepRhythmAIK210822 · 510(k) | Medicalgorithmics S.A. | Cardiovascular | database entry | |
| ZEUS SystemK213409 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry | |
| AliveCor QT ServiceK212662 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| IM007K210543 · 510(k) | Implicity, Inc. | Cardiovascular | database entry | |
| Zio ECG Utilization SoftwareK202527 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry | |
| KardiaAIK201985 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| VX1K201298 · 510(k) | Volta Medical | Cardiovascular | database entry | |
| Zio XT ECG Monitoring System, Zio AT ECG MonitorK190593 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry | |
| KardiaAIK181823 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| RhythmAnalyticsK182344 · 510(k) | Biofourmis Singapore Pte. Ltd. | Cardiovascular | database entry | |
| AI-ECG PlatformK180432 · 510(k) | Shenzhen Carewell Electronics., Ltd | Cardiovascular | database entry | |
| Zio AT ECG Monitoring System, ZEUS SystemK181502 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | database entry |
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