Cleared Traditional

K200964 - Sonosite PX Ultrasound System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200964 · FUJIFILM Sonosite, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
28d
Days
Class 2
Risk

K200964 is an FDA 510(k) clearance for the Sonosite PX Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on May 8, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all FUJIFILM Sonosite, Inc. devices

Submission Details

510(k) Number K200964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2020
Decision Date May 08, 2020
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1158
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K200964.
ES-Series
K260589 · E-Scopics · Apr 2026
6450 Ultrasound System (MyLabE80)
K253288 · Esaote, S.P.A. · Apr 2026
Wireless Probe Type Ultrasound Scanner
K252709 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · Apr 2026
EVO Q30 Diagnostic Ultrasound System
K254099 · Samsung Medison Co., Ltd. · Mar 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K253595 · Philips Ultrasound, LLC · Mar 2026
Butterfly Gestational Age Tool
K252148 · Butterfly Network, Inc. · Mar 2026