Cleared Special

K163427 - X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System

K163427 is an FDA 510(k) clearance for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Colo..., manufactured by Sonoscape Medical Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 28-day FDA review.

K163427 · Sonoscape Medical Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
28d
Days
Class 2
Risk

K163427 is an FDA 510(k) clearance for the X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler 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 Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on January 3, 2017 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. 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.

FDA 510(k) Submission Details - K163427

510(k) Number K163427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2016
Decision Date January 03, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 1187
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K163427.
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K162845 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2016
ARIETTA Prologue Diagnostic Ultrasound system and Transducers
K162902 · Hitachi , Ltd. · Dec 2016
Clarius Ultrasound System
K163138 · Clarius Mobile Health Corp. · Nov 2016
K163427 · X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
Download PDF FDA Summary Sonoscape Medical Cor…