Submission Details
| 510(k) Number | K251106 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2025 |
| Decision Date | August 29, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Sonosite LX and Sonosite PX Ultrasound Systems
Aug 2025
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K251106 is an FDA 510(k) clearance for the Sonosite LX and Sonosite PX Ultrasound Systems, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on August 29, 2025, 140 days after receiving the submission on April 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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