NeuTrace EP Mapping System v.2.1
FDA 510(k) K233160 · Anumana, Inc.
510(k) numberK233160
Submission
- Device name
- NeuTrace EP Mapping System v.2.1
- Applicant
- Anumana, Inc.
Cambridge, MA, US - Received
- September 27, 2023
- Decision date
- November 25, 2023
- 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 |
|---|---|---|
| K260300 | WatchMate SoftwareQIH · Traditional | 06/15/2026SE |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)SHP · Traditional | 04/07/2026SE |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)SAT · Traditional | 03/28/2026SE |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)QYE · Traditional | 07/28/2025SE |
| K232699 | Low Ejection Fraction AI-ECG AlgorithmQYE · Traditional | 09/28/2023SE |
Questions and answers
When was NeuTrace EP Mapping System v.2.1 cleared by the FDA?
NeuTrace EP Mapping System v.2.1 (K233160) received a 510(k) decision of Substantially Equivalent on November 25, 2023, 59 days after the submission was received.
What is the product code of K233160?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.