Cleared Traditional

K131213 - DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

K131213 is an FDA 510(k) clearance for DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, manufactured by Sonoscape Company Limited. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K131213 · Sonoscape Company Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
53d
Days
Class 2
Risk

K131213 is an FDA 510(k) clearance for the 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 Company Limited (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on June 21, 2013 after a review of 53 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 Company Limited devices

FDA 510(k) Submission Details - K131213

510(k) Number K131213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2013
Decision Date June 21, 2013
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
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 890
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K131213.
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
K132304 · Philips Ultrasound, Inc. · Aug 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2013
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K130833 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2013
Z5 DIAGNOSTIC ULTRASOUND SYSTEM
K130695 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2013
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
K131267 · Ge Healthcare · Jun 2013
IU22 DIAGNOSTIC ULTRASOUND SYSTEM
K130499 · Philips Ultrasound, Inc. · Jun 2013