ScioCardio ECG Analysis Platform
FDA 510(k) K252978 · Synergen Technology Labs, LLC
510(k) numberK252978
Submission
- Device name
- ScioCardio ECG Analysis Platform
- Applicant
- Synergen Technology Labs, LLC
Dallas, TX, US - Received
- September 17, 2025
- Decision date
- July 9, 2026
- 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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| 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 |
| 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 |
| K260212 | EnSite X EP SystemDQK · Traditional | Abbott Medical | 04/20/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K171019 | ScioCardio ECG TransmitterDRG · Traditional | 05/30/2018SE |
Questions and answers
When was ScioCardio ECG Analysis Platform cleared by the FDA?
ScioCardio ECG Analysis Platform (K252978) received a 510(k) decision of Substantially Equivalent on July 9, 2026, 295 days after the submission was received.
What is the product code of K252978?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.