DQK · Computer, Diagnostic, Programmable

Device class

Class II

Regulation 870.1425

Total clearances

125

2020-02-11 → 2026-07-26

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1425

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
ABBOTT MEDICAL	13	4	2026-07-15
Edwards Lifesciences	11	3	2026-02-24
Acutus Medical, Inc.	8	0	2023-07-10
Biosense Webster, Inc.	8	2	2026-02-20
Boston Scientific	7	0	2025-05-28
Centerline Biomedical, Inc.	6	2	2026-06-10
Volta Medical	5	1	2025-09-12
Medicalgorithmics S.A.	4	1	2025-12-11
iRhythm Technologies, Inc.	4	1	2026-05-29
Medtronic, Inc.	4	0	2025-01-17
Philips Medical Systems Nederland B.V.	3	1	2025-10-24
Abbott	3	0	2022-08-18
Ge Medical Systems Information Technologies, Inc.	3	0	2024-12-12
Rhythm AI, Ltd.	2	1	2025-12-19
Imricor Medical Systems	2	2	2026-06-30
Cardiocalm Srl	2	0	2025-02-20
AliveCor, Inc.	2	0	2022-04-26
Implicity, Inc.	2	1	2026-07-02
Coroventis Research AB	2	1	2025-10-24
Vektor Medical, Inc.	2	1	2025-12-04
Ablacon, Inc.	2	0	2023-06-08
Cath Vision Aps	2	0	2023-08-04
Anumana, Inc.	1	0	2023-11-25
Edwards Lifeciences, LLC	1	0	2022-11-07
Philips Medical System Nederland B.V.	1	0	2020-12-17

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	Medium	Diagnostic computer programmable may support cardiac interpretation services

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-26	K253576	Analytics For Life, Inc.	CorVista System® with PCWP Add-On
2026-07-15	K262006	Abbott Medical	EnSite X EP System
2026-07-09	K252978	Synergen Technology Labs, LLC	ScioCardio ECG Analysis Platform
2026-07-02	K253463	Implicity, Inc.	ILR ECG Analyzer (IM007)
2026-06-30	K261119	Imricor Medical Systems, Inc.	NorthStar Mapping System (MAP01 or MAP01-01)
2026-06-12	K253088	Micropace Pty, Ltd.	OneStim-DUO Cardiac Stimulator (MP5003-4CO)
2026-06-10	K261329	Centerline Biomedical	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)
2026-05-29	K252859	iRhythm Technologies, Inc.	ZEUS Platform (FG0501US)
2026-04-20	K260212	ABBOTT MEDICAL	EnSite X EP System
2026-04-13	K253861	Corify Care S.L	ACORYS MAPPING SYSTEM
2026-04-01	K253473	Stereotaxis, Inc.	Synchrony
2026-02-24	K253186	Edwards Lifesciences, LLC	HemoSphere Nano Monitor (HSNANO1)
2026-02-20	K252972	Biosense Webster, Inc.	CARTO 3 EP Navigation System V8.4
2026-02-17	K254089	Centerline Biomedical, Inc.	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)
2026-02-09	K251591	Edan Instruments, Inc.	Holter ECG and ABP system (HolterABP)
2026-02-06	K251218	SafeBeat Rx, Inc.	SafeBeat Rx App
2026-01-28	K252164	Imricor Medical Systems	NorthStar Mapping System
2026-01-18	K254085	Biosense Webster, Inc.	CARTO 3 EP Navigation System V9.0 with PIU Plus
2025-12-19	K253733	Rhythm AI, Ltd.	STAR Apollo Mapping System
2025-12-18	K252533	Edwards Lifesciences	HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
2025-12-11	K253141	Medicalgorithmics S.A.	DeepRhythmAI
2025-12-04	K252429	Vektor Medical, Inc.	Vektor Computational ECG Mapping System (vMap®)
2025-10-24	K252645	Philips Medical Systems Nederland B.V.	LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
2025-10-24	K252238	Coroventis Research AB	CoroFlow Cardiovascular System
2025-10-21	K253034	Edwards Lifesciences	HemoSphere Stream Module