EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
FDA 510(k) K251463 · Abbott Medical
510(k) numberK251463
Submission
- Device name
- EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
- Applicant
- Abbott Medical
St. Paul, MN, US - Received
- May 12, 2025
- Decision date
- September 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262006 | EnSite X EP SystemDQK · Special | 07/15/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | 06/17/2026SE |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | 04/24/2026SE |
| K260212 | EnSite X EP SystemDQK · Traditional | 04/20/2026SE |
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | 04/16/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | 03/13/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | 02/13/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | 12/18/2025SE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045)DQY · Traditional | 12/17/2025SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | 10/29/2025SE |
Questions and answers
When was EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) cleared by the FDA?
EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463) received a 510(k) decision of Substantially Equivalent on September 4, 2025, 115 days after the submission was received.
What is the product code of K251463?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.