Vivid E80, Vivid E90, Vivid E95
FDA 510(k) clearance K181685 · decided 2018-10-25
Clearance details
- K-number
- K181685
- Device name
- Vivid E80, Vivid E90, Vivid E95
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2018-06-26
- Decision date
- 2018-10-25
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.