GE Vingmed Ultrasound As
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2317-2024 | Class II | GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW | May 2, 2024 |
| Z-2316-2024 | Class II | GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA | May 2, 2024 |
| Z-2126-2023 | Class II | GE Healthcare Vivid S60N, ultrasound device | May 30, 2023 |
| Z-2124-2023 | Class II | GE Healthcare Vivid S60, ultrasound device | May 30, 2023 |
| Z-2127-2023 | Class II | GE Healthcare Vivid S70N, ultrasound device | May 30, 2023 |
| Z-2125-2023 | Class II | GE Healthcare Vivid S70, ultrasound device | May 30, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivi | March 4, 2015 |
| K150085 | GE EchoPAC | March 2, 2015 |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | May 15, 2014 |
| K131685 | GE ECHOPAC | September 24, 2013 |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | July 12, 2013 |
| K123894 | GE ECHOPAC | January 29, 2013 |
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | April 19, 2012 |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | October 13, 2010 |
| K101324 | GE ECHOPAC MODEL BT10 | October 5, 2010 |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | September 28, 2009 |
| K991842 | SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING | June 11, 1999 |