Cleared Special

K083114 - ACUSON P50 ULTRASOUND SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083114 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
161d
Days
Class 2
Risk

K083114 is an FDA 510(k) clearance for the ACUSON P50 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 Siemens Medical Solutions USA, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 161 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K083114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2008
Decision Date March 31, 2009
Days to Decision 161 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Modification to existing cleared device.

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 K083114.
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