DQK — Computer, Diagnostic, Programmable Class II
FDA product code DQK covers "Computer, Diagnostic, Programmable", a Class II medical device regulated under 21 CFR 870.1425. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DQK
- Device Class
- Class II
- Regulation Number
- 870.1425
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261729 | abbott medical | EnSite X EP System | September 17, 2026 |
| K262005 | medtronic | Affera Integrated Mapping System | August 21, 2026 |
| K253692 | boston scientific | AVVIGO+ Multi-Modality Guidance System | August 21, 2026 |
| K253576 | analytics for life | CorVista System® with PCWP Add-On | July 26, 2026 |
| K262006 | abbott medical | EnSite X EP System | July 15, 2026 |
| K252978 | synergen technology labs | ScioCardio ECG Analysis Platform | July 9, 2026 |
| K253463 | implicity | ILR ECG Analyzer (IM007) | July 2, 2026 |
| K261119 | imricor medical systems | NorthStar Mapping System (MAP01 or MAP01-01) | June 30, 2026 |
| K253088 | micropace pty | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | June 12, 2026 |
| K261329 | centerline biomedical | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Cat | June 10, 2026 |
| K252859 | irhythm technologies | ZEUS Platform (FG0501US) | May 29, 2026 |
| K260212 | abbott medical | EnSite X EP System | April 20, 2026 |
| K253861 | corify care s.l | ACORYS MAPPING SYSTEM | April 13, 2026 |
| K253473 | stereotaxis | Synchrony | April 1, 2026 |
| K253186 | edwards lifesciences | HemoSphere Nano Monitor (HSNANO1) | February 24, 2026 |
| K252972 | biosense webster | CARTO 3 EP Navigation System V8.4 | February 20, 2026 |
| K254089 | centerline biomedical | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751 | February 17, 2026 |
| K251591 | edan instruments | Holter ECG and ABP system (HolterABP) | February 9, 2026 |
| K251218 | safebeat rx | SafeBeat Rx App | February 6, 2026 |
| K252164 | imricor medical systems | NorthStar Mapping System | January 28, 2026 |