Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Waukesha
- Advisory committee description
- Radiology
- Address 1
- 3200 N Grandview Blvd.
- Statement or summary
- Summary
- Product code
- IYN
- Zip code
- 53188
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision date
- 2026-09-02
- Decision code
- SESE
- Country code
- US
- Device name
- Vivid Explorer/Vivid Advanced/Vivid Focus
- Advisory committee
- RA
- Contact
- Yuan Wang
- K number
- K261313
- State
- WI
- Date received
- 2026-04-21
- Review advisory committee
- RA
- Postal code
- 53188
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty description
- Radiology
- Regulation number
- 892.1550
- Device class
- 2
- Registration number
- 8043836, 2939830, 3031823165, 3003774756, 3010760216, 1000601180, 3016076141, 3027501622, 3004753388, 3006680097, 3005334138, 3033527283, 3003594449, 2029275, 3010041511, 9710090, 3014755924, 9617277, 3010952312, 3014574557, 3033508292, 3019216, 1062741, 1416980, 3012981490, 1643817, 3021591288, 3007836437, 3042228064, 3033858858, 3003600763, 3002619337, 3012761544, 3012747207, 3010082909, 3025786376, 3010398867, 3031397684, 3003589956, 3003971136 +182 more
- FEI number
- 3031823165, 3003774756, 3010760216, 1000601180, 3016076141, 3027501622, 3004753388, 3006680097, 3005334138, 3003309342, 3033527283, 3002087856, 3010289997, 3003594449, 3010041511, 3000302153, 3002827704, 3014755924, 3010952312, 3014574557, 3003190524, 3033508292, 3019216, 1416980, 3012981490, 1643817, 3021591288, 3007836437, 3042228064, 3000957797, 3033858858, 3003600763, 3002619337, 3002626007, 3012761544, 3012747207, 3010082909, 3025786376, 3010398867, 3031397684 +182 more