DQK · Computer, Diagnostic, Programmable
Cardiovascular · 21 CFR 870.1425 · Class 2
Overview
| Product Code | DQK |
|---|---|
| Device Name | Computer, Diagnostic, Programmable |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | ACORYS MAPPING SYSTEM | Corify Care S.L | Apr 13, 2026 | SESE |
| K253473 | Synchrony | Stereotaxis, Inc. | Apr 1, 2026 | SESE |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | Feb 24, 2026 | SESE |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | Feb 20, 2026 | SESE |
| K254089 | 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 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | Feb 9, 2026 | SESE |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | Feb 6, 2026 | SESE |
| K252164 | NorthStar Mapping System | Imricor Medical Systems | Jan 28, 2026 | SESE |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster, Inc. | Jan 18, 2026 | SESE |
| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | Dec 19, 2025 | SESE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | Dec 18, 2025 | SESE |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | Dec 11, 2025 | SESE |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | Dec 4, 2025 | SESE |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | Oct 24, 2025 | SESE |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | Oct 24, 2025 | SESE |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | Oct 21, 2025 | SESE |
| K252013 | EnSite X EP System | ABBOTT MEDICAL | Sep 25, 2025 | SESE |
| K251518 | Volta AF-Xplorer II | Volta Medical | Sep 12, 2025 | SESE |
| K251463 | 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 | 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
