FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sonosite LX and Sonosite PX Ultrasound Systems
K Number: K251106
·
Decision Aug 29, 2025
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
25
Review Days
140
Basic Information
- Device Name
- Sonosite LX and Sonosite PX Ultrasound Systems
- K Number
- K251106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Sonosite, Inc.
- Date Received
- April 11, 2025
- Decision Date
- August 29, 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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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 |
| 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 |
| K180704 | SonoSite iViz Ultrasound System | Apr 13, 2018 | Substantially Equivalent |