FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SonoSite iViz Ultrasound System
K Number: K180704
·
Decision Apr 13, 2018
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
25
Review Days
25
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Basic Information
- Device Name
- SonoSite iViz Ultrasound System
- K Number
- K180704
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Sonosite, Inc.
- Date Received
- March 19, 2018
- Decision Date
- April 13, 2018
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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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SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by FUJIFILM Sonosite, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260595 | Sonosite iLOOK Ultrasound System | Mar 10, 2026 | Substantially Equivalent |
| K253448 | Sonosite MT Ultrasound System | Nov 3, 2025 | Substantially Equivalent |
| K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | Aug 29, 2025 | Substantially Equivalent |
| K251830 | Sonosite LX Ultrasound System | Jul 10, 2025 | Substantially Equivalent |
| K233597 | Sonosite LX Ultrasound System | Dec 6, 2023 | Substantially Equivalent |
| K213763 | Sonosite PX Ultrasound System | Dec 27, 2021 | Substantially Equivalent |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | Sep 1, 2020 | Substantially Equivalent |
| K200964 | Sonosite PX Ultrasound System | May 8, 2020 | Substantially Equivalent |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | Mar 15, 2019 | Substantially Equivalent |
| K183235 | SonoSite SII Ultrasound System | Feb 7, 2019 | Substantially Equivalent |