AcQMap High Resolution Imaging and Mapping System
FDA 510(k) K210680 · Acutus Medical, Inc.
510(k) numberK210680
Submission
- Device name
- AcQMap High Resolution Imaging and Mapping System
- Applicant
- Acutus Medical, Inc.
Carlsbad, CA, US - Received
- March 8, 2021
- Decision date
- August 5, 2021
- 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K233691 | FlexCath Cross Transseptal SolutionDYB · Traditional | 12/17/2023SE |
| K231091 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/10/2023SE |
| K230606 | AcQMap® High Resolution Imaging and Mapping SystemDQK · Traditional | 05/02/2023SE |
| K222209 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 10/17/2022SE |
| K220784 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | 07/01/2022SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | 06/21/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | 05/05/2022SE |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/NeedleDYB · Traditional | 02/08/2022SE |
| K212345 | AcQMap High Resolution Imaging and Mapping SystemDQK · Special | 08/27/2021SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | 05/14/2021SE |
Questions and answers
When was AcQMap High Resolution Imaging and Mapping System cleared by the FDA?
AcQMap High Resolution Imaging and Mapping System (K210680) received a 510(k) decision of Substantially Equivalent on August 5, 2021, 150 days after the submission was received.
What is the product code of K210680?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.