Cleared Traditional

K173000 - Apogee 2100 Digital Color Doppler Ultra...

K173000 is an FDA 510(k) clearance for Apogee 2100 Digital Color Doppler Ultra..., manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K173000 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
71d
Days
Class 2
Risk

K173000 is an FDA 510(k) clearance for the Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digit.... 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (Shantou, CN). The FDA issued a Cleared decision on December 7, 2017 after a review of 71 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) devices

FDA 510(k) Submission Details - K173000

510(k) Number K173000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date December 07, 2017
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
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 922
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K173000.
LOGIQ E10
K173555 · Ge Healthcare · Dec 2017
E-CUBE 8
K172732 · Alpinion Medical Systems Co., Ltd. · Dec 2017
Xario 200 Diagnostic Ultrasound System V6.0
K172276 · Toshibamedical Systems Corporation · Dec 2017
P20 Series Digital Color Doppler Ultrasound System
K172993 · Sonoscape Medical Corp. · Dec 2017
P10 Series Digital Color Doppler Ultrasound System
K173058 · Sonoscape Medical Corp. · Dec 2017
U50 Diagnostic Ultrasound System
K173003 · Edan Instruments, Inc. · Nov 2017