ScioCardio ECG Analysis Platform— 510(k) K252978
Substantially EquivalentSynergen Technology Labs, LLC
FDA 510(k) clearance K252978 for ScioCardio ECG Analysis Platform, Substantially Equivalent on 2026-07-09. Applicant: Synergen Technology Labs, LLC. Device class: 2.
Summary
Synergen Technology Labs' ScioCardio ECG Analysis Platform is filed under DQK, programmable diagnostic computers. The record doesn't describe the platform's outputs.
Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Synergen filed from Dallas, Texas. The decision came 295 calendar days after FDA received it (September 17, 2025 to July 9, 2026).
Clearance details
- Applicant
- Synergen Technology Labs, LLC
- Product code
- Product code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code DQK
view allMore clearances from Synergen Technology Labs, LLC
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.