Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1425](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1425) → DQK — Computer, Diagnostic, Programmable # DQK · Computer, Diagnostic, Programmable _Cardiovascular · 21 CFR 870.1425 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK ## Overview - **Product Code:** DQK - **Device Name:** Computer, Diagnostic, Programmable - **Regulation:** [21 CFR 870.1425](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1425) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 426) Showing 20 most recent of 426 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253861](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253861.md) | ACORYS MAPPING SYSTEM | Corify Care S.L | Apr 13, 2026 | SESE | | [K253473](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253473.md) | Synchrony | Stereotaxis, Inc. | Apr 1, 2026 | SESE | | [K253186](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253186.md) | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | Feb 24, 2026 | SESE | | [K252972](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252972.md) | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | Feb 20, 2026 | SESE | | [K254089](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K254089.md) | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | Feb 17, 2026 | SESE | | [K251591](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K251591.md) | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | Feb 9, 2026 | SESE | | [K251218](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K251218.md) | SafeBeat Rx App | SafeBeat Rx, Inc. | Feb 6, 2026 | SESE | | [K252164](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252164.md) | NorthStar™ Mapping System | Imricor Medical Systems | Jan 28, 2026 | SESE | | [K254085](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K254085.md) | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | Jan 18, 2026 | SESE | | [K253733](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253733.md) | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | Dec 19, 2025 | SESE | | [K252533](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252533.md) | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | Dec 18, 2025 | SESE | | [K253141](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253141.md) | DeepRhythmAI | Medicalgorithmics S.A. | Dec 11, 2025 | SESE | | [K252429](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252429.md) | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | Dec 4, 2025 | SESE | | [K252645](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252645.md) | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Oct 24, 2025 | SESE | | [K252238](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252238.md) | CoroFlow Cardiovascular System | Coroventis Research AB | Oct 24, 2025 | SESE | | [K253034](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K253034.md) | HemoSphere Stream Module | Edwards Lifesciences | Oct 21, 2025 | SESE | | [K252013](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252013.md) | EnSite™ X EP System | ABBOTT MEDICAL | Sep 25, 2025 | SESE | | [K251518](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K251518.md) | Volta AF-Xplorer II | Volta Medical | Sep 12, 2025 | SESE | | [K251463](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K251463.md) | EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) | ABBOTT MEDICAL | Sep 4, 2025 | SESE | | [K252302](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK/K252302.md) | CARTO™ 3 EP Navigation System V8.1 | Biosense Webster, Inc. | Aug 22, 2025 | SESE | ## Top Applicants - Biosense Webster, Inc. — 34 clearances - St Jude Medical — 23 clearances - Acutus Medical, Inc. — 12 clearances - Edwards Lifesciences, LLC — 12 clearances - ABBOTT MEDICAL — 11 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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