Cleared Traditional

K173058 - P10 Series Digital Color Doppler Ultrasound System

K173058 is an FDA 510(k) clearance for P10 Series Digital Color Doppler Ultras..., manufactured by Sonoscape Medical Corp.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K173058 · Sonoscape Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
64d
Days
Class 2
Risk

K173058 is an FDA 510(k) clearance for the P10 Series 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 December 1, 2017 after a review of 64 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 Sonoscape Medical Corp. devices

FDA 510(k) Submission Details - K173058

510(k) Number K173058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date December 01, 2017
Days to Decision 64 days
Submission Type Traditional
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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1085
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K173058.
Xario 200 Diagnostic Ultrasound System V6.0
K172276 · Toshibamedical Systems Corporation · Dec 2017
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
K173000 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Dec 2017
P20 Series Digital Color Doppler Ultrasound System
K172993 · Sonoscape Medical Corp. · Dec 2017
U50 Diagnostic Ultrasound System
K173003 · Edan Instruments, Inc. · Nov 2017
Dolphin/IQ and Dolphin/4D
K170859 · Viasonix , Ltd. · Nov 2017
UltraVision 2 Diagnostic Ultrasound System
K173265 · Winprobe Corporation · Nov 2017