FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vivid Pioneer
K Number: K251169
·
Decision Jul 10, 2025
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
25
Review Days
86
Basic Information
- Device Name
- Vivid Pioneer
- K Number
- K251169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Date Received
- April 15, 2025
- Decision Date
- July 10, 2025
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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