Cleared Special

K162221 - ACUSON SC2000 Diagnostic Ultrasound System

K162221 is an FDA 510(k) clearance for ACUSON SC2000 Diagnostic Ultrasound System, manufactured by Siemens Medical Solutions Inc. Ultrasound Group. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 29-day FDA review.

K162221 · Siemens Medical Solutions Inc. Ultrasound Group · Radiology device
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Sep 2016
Decision
29d
Days
Class 2
Risk

K162221 is an FDA 510(k) clearance for the ACUSON SC2000 Diagnostic 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 Inc. Ultrasound Group (Moutain View, US). The FDA issued a Cleared decision on September 6, 2016 after a review of 29 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. 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. Low regulatory complexity profile. 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 Inc. Ultrasound Group devices

FDA 510(k) Submission Details - K162221

510(k) Number K162221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date September 06, 2016
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

IYN Device Classification - Class 2, Special Controls

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 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K162221.
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
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