EchoPAC Software Only v113
EchoPAC Software Only v113 is a Class II device made by GE Vingmed Ultrasound A/S, cleared under FDA 510(k) K131685 on 24 Sep 2013 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00840682121095), 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 | Number00840682121095 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK131685 | Date24 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 00840682121095
- FDA 510(k) database K131685
Across registries
- FDA 510(k) K131685 decided 24 Sep 2013 Active
- FDA GUDID UDI-DI 00840682121095 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131685
- Listed FDA GUDID 00840682121095
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EchoPAC
- Generic name
- Ultrasound imaging system application software
- Model / reference
- Software Only v113
- Primary DI / UDI-DI
- 00840682121095
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Ultrasound imaging system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ultrasound imaging system application software.