DQK
- 产品代码
- DQK
- 器械名称
- Computer, Diagnostic, Programmable
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.1425
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 437 件
该代码近三年的 510(k)（61 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253692 | 2026-08-21 | Boston Scientific | AVVIGO+ Multi-Modality Guidance System | |
| K262005 | 2026-08-21 | Medtronic, Inc. | Affera Integrated Mapping System | |
| K253576 | 2026-07-26 | Analytics For Life, Inc. | CorVista System® with PCWP Add-On | |
| K262006 | 2026-07-15 | Abbott Medical | EnSite X EP System | |
| K252978 | 2026-07-09 | Synergen Technology Labs, LLC | ScioCardio ECG Analysis Platform | |
| K253463 | 2026-07-02 | Implicity, Inc. | ILR ECG Analyzer (IM007) | |
| K261119 | 2026-06-30 | Imricor Medical Systems, Inc. | NorthStar Mapping System (MAP01 or MAP01-01) | |
| K253088 | 2026-06-12 | Micropace Pty, Ltd. | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | |
| K261329 | 2026-06-10 | Centerline Biomedical | Intra-Operative Positioning System (IOPS) (MC-1);IOP | |
| K252859 | 2026-05-29 | iRhythm Technologies, Inc. | ZEUS Platform (FG0501US) | |
| K260212 | 2026-04-20 | ABBOTT MEDICAL | EnSite X EP System | |
| K253861 | 2026-04-13 | Corify Care S.L | ACORYS MAPPING SYSTEM | |
| K253473 | 2026-04-01 | Stereotaxis, Inc. | Synchrony | |
| K253186 | 2026-02-24 | Edwards Lifesciences, LLC | HemoSphere Nano Monitor (HSNANO1) | |
| K252972 | 2026-02-20 | Biosense Webster, Inc. | CARTO 3 EP Navigation System V8.4 | |
| K254089 | 2026-02-17 | Centerline Biomedical, Inc. | IOPS Visionary System (MC-3); IOPS Viewpoint Simple | |
| K251591 | 2026-02-09 | Edan Instruments, Inc. | Holter ECG and ABP system (HolterABP) | |
| K251218 | 2026-02-06 | SafeBeat Rx, Inc. | SafeBeat Rx App | |
| K252164 | 2026-01-28 | Imricor Medical Systems | NorthStar Mapping System | FDA |
| K254085 | 2026-01-18 | Biosense Webster, Inc. | CARTO 3 EP Navigation System V9.0 with PIU Plus | |
| K253733 | 2025-12-19 | Rhythm AI, Ltd. | STAR Apollo Mapping System | |
| K252533 | 2025-12-18 | Edwards Lifesciences | HemoSphere Alta Advanced Monitoring Platform (ALTAAL | |
| K253141 | 2025-12-11 | Medicalgorithmics S.A. | DeepRhythmAI | |
| K252429 | 2025-12-04 | Vektor Medical, Inc. | Vektor Computational ECG Mapping System (vMap®) | |
| K252238 | 2025-10-24 | Coroventis Research AB | CoroFlow Cardiovascular System | |
| K252645 | 2025-10-24 | Philips Medical Systems Nederland B.V. | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide | |
| K253034 | 2025-10-21 | Edwards Lifesciences | HemoSphere Stream Module | |
| K252013 | 2025-09-25 | ABBOTT MEDICAL | EnSite X EP System | |
| K251518 | 2025-09-12 | Volta Medical | Volta AF-Xplorer II | |
| K251463 | 2025-09-04 | ABBOTT MEDICAL | EnSite X EP System, AutoMark Index Software License | |
| K252302 | 2025-08-22 | Biosense Webster, Inc. | CARTO 3 EP Navigation System V8.1 | |
| K251234 | 2025-07-30 | ABBOTT MEDICAL | EnSite X EP System | |
| K243781 | 2025-07-23 | Edwards Lifesciences | HemoSphere Advanced Monitor (HEM1); HemoSphere Techn | |
| K250747 | 2025-06-25 | Kardium, Inc. | Globe® Pulsed Field System | |
| K250749 | 2025-06-04 | Physcade, Inc. | PhysCade System | |
| K251344 | 2025-05-28 | Boston Scientific Corporation | OptiMap System | |
| K250932 | 2025-05-27 | Medicalgorithmics S.A. | DeepRhythmAI | |
| K243812 | 2025-05-09 | Volta Medical | Volta AF-Xplorer | |
| K242129 | 2025-04-17 | Vitalconnect, Inc. | VitalRhythm | |
| K243842 | 2025-03-06 | Centerline Biomedical, Inc. | Intra-Operative Positioning System (IOPS®) | |
| K243312 | 2025-02-20 | Cardiocalm Srl | CER-S | |
| K243892 | 2025-01-17 | Medtronic, Inc. | Affera Integrated Mapping System | |
| K243540 | 2024-12-12 | Ge Medical Systems Information Technol | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboL | |
| K243435 | 2024-12-05 | Medtronic, Inc. | Magnetic Localization Patch Kit (AFR-00021) | |
| K241197 | 2024-12-04 | Medicalgorithmics S.A. | DeepRhythmAI | FDA |
| K241828 | 2024-11-01 | Medtronic, Inc. | Affera Integrated Mapping System; Impedance Localiza | |
| K242133 | 2024-10-11 | Centerline Biomedical, Inc. | Intra-Operative Positioning System (IOPS®) (Fiducial | |
| K241227 | 2024-08-29 | Boston Scientific Corporation | RHYTHMIA HDx Mapping System | FDA |
| K233755 | 2024-08-16 | B-Secur Limited | HeartKey® Rhythm | |
| K242016 | 2024-08-09 | ABBOTT MEDICAL | EnSite X EP System | |
| K240509 | 2024-07-26 | Rhythm AI, Ltd. | STAR Apollo Mapping System | FDA |
| K241243 | 2024-07-24 | Centerline Biomedical, Inc. | Intra-Operative Positioning System (IOPS®) Viewpoint | FDA |
| K233326 | 2024-06-21 | Merge Healthcare Incorporated | Merge Hemo, Model RCSV2 | |
| K233853 | 2024-03-14 | Philips Medical Systems Nederland B.V. | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide | FDA |
| K233943 | 2024-03-08 | Medtronic, Inc. | Affera Mapping System (AFR-00003); Location Referenc | |
| K231870 | 2023-12-13 | Ge Medical Systems Information Technol | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 | |
| K233160 | 2023-11-25 | Anumana, Inc. | NeuTrace EP Mapping System v.2.1 | |
| K232294 | 2023-10-31 | Edwards Lifesciences, LLC | HemoSphere Alta Advanced Monitoring Platform; HemoSp | |
| K232616 | 2023-09-27 | Volta Medical | Volta AF-Xplorer | |
| K230884 | 2023-09-26 | Boston Scientific Corporation | AVVIGO'+ Multi-Modality Guidance System | |
| K223812 | 2023-09-15 | Siemens Medical Solutions USA, Inc. | Sensis Vibe (VD15) |
FDA 官方分类页： DQK
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。