EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
FDA 510(k) K201148 · Abbott Medical
510(k) numberK201148
Submission
- Device name
- EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License
- Applicant
- Abbott Medical
St. Paul, MN, US - Received
- April 29, 2020
- Decision date
- June 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
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| 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 Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License cleared by the FDA?
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License (K201148) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 58 days after the submission was received.
What is the product code of K201148?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.