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-staging.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 437)

Showing 20 most recent of 437 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262005](/device/K262005.md) | Affera Integrated Mapping System | Medtronic, Inc. | Aug 21, 2026 | SESE |
| [K253692](/device/K253692.md) | AVVIGO™+ Multi-Modality Guidance System | Boston Scientific | Aug 21, 2026 | SESE |
| [K253576](/device/K253576.md) | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | Jul 26, 2026 | SESE |
| [K262006](/device/K262006.md) | EnSite™ X EP System | Abbott Medical | Jul 15, 2026 | SESE |
| [K252978](/device/K252978.md) | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | Jul 9, 2026 | SESE |
| [K253463](/device/K253463.md) | ILR ECG Analyzer (IM007) | Implicity, Inc. | Jul 2, 2026 | SESE |
| [K261119](/device/K261119.md) | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | Jun 30, 2026 | SESE |
| [K253088](/device/K253088.md) | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | Jun 12, 2026 | SESE |
| [K261329](/device/K261329.md) | Intra-Operative Positioning System (IOPS) (MC-1);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 | Jun 10, 2026 | SESE |
| [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 |

## 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-staging.innolitics.com/productcode/DQK](https://fda-staging.innolitics.com/productcode/DQK)

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