Mycardium 01.01.00(USA)
Mycardium 01.01.00(USA) (EchoConfidence) is a Class II device made by Mycardium AI Limited, cleared under FDA 510(k) K250670 on 30 Jun 2025 and listed in FDA GUDID since 11 Jul 2025 (UDI-DI 05061038730050), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05061038730050 | Date11 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250670 | Date30 Jun 2025 | StatusActive |
Official records
- AccessGUDID record 05061038730050
- FDA 510(k) database K250670
Across registries
- FDA 510(k) K250670 decided 30 Jun 2025 Active
- FDA GUDID UDI-DI 05061038730050 listed 11 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K250670
- Listed FDA GUDID 05061038730050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mycardium
- Generic name
- Cardiac mapping system application software
- Model / Ref / Catalog
- 01.01.00(USA), EchoConfidence
- Primary DI / UDI-DI
- 05061038730050
- 510(k) Number
- FDA product code
- QIH
- GMDN term
- Cardiac mapping system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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