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/productcode/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 428)

Showing 20 most recent of 428 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252859](/device/K252859.md) | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | May 29, 2026 | SESE |
| [K260212](/device/K260212.md) | EnSite™ X EP System | ABBOTT MEDICAL | Apr 20, 2026 | SESE |
| [K253861](/device/K253861.md) | ACORYS MAPPING SYSTEM | Corify Care S.L | Apr 13, 2026 | SESE |
| [K253473](/device/K253473.md) | Synchrony | Stereotaxis, Inc. | Apr 1, 2026 | SESE |
| [K253186](/device/K253186.md) | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | Feb 24, 2026 | SESE |
| [K252972](/device/K252972.md) | CARTO™ 3 EP Navigation System V8.4 | Biosense Webster, Inc. | Feb 20, 2026 | SESE |
| [K254089](/device/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](/device/K251591.md) | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | Feb 9, 2026 | SESE |
| [K251218](/device/K251218.md) | SafeBeat Rx App | SafeBeat Rx, Inc. | Feb 6, 2026 | SESE |
| [K252164](/device/K252164.md) | NorthStar™ Mapping System | Imricor Medical Systems | Jan 28, 2026 | SESE |
| [K254085](/device/K254085.md) | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | Jan 18, 2026 | SESE |
| [K253733](/device/K253733.md) | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | Dec 19, 2025 | SESE |
| [K252533](/device/K252533.md) | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | Dec 18, 2025 | SESE |
| [K253141](/device/K253141.md) | DeepRhythmAI | Medicalgorithmics S.A. | Dec 11, 2025 | SESE |
| [K252429](/device/K252429.md) | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | Dec 4, 2025 | SESE |
| [K252645](/device/K252645.md) | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Oct 24, 2025 | SESE |
| [K252238](/device/K252238.md) | CoroFlow Cardiovascular System | Coroventis Research AB | Oct 24, 2025 | SESE |
| [K253034](/device/K253034.md) | HemoSphere Stream Module | Edwards Lifesciences | Oct 21, 2025 | SESE |
| [K252013](/device/K252013.md) | EnSite™ X EP System | ABBOTT MEDICAL | Sep 25, 2025 | SESE |
| [K251518](/device/K251518.md) | Volta AF-Xplorer II | Volta Medical | Sep 12, 2025 | SESE |

## Top Applicants

- Biosense Webster, Inc. — 34 clearances
- St Jude Medical — 23 clearances
- ABBOTT MEDICAL — 12 clearances
- Acutus Medical, Inc. — 12 clearances
- Edwards Lifesciences, LLC — 12 clearances

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**Source:** [https://fda.innolitics.com/productcode/DQK](https://fda.innolitics.com/productcode/DQK)

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