Cleared Traditional

SmartUs EXT-1M/3M (K163121) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163121 · Telemed · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
275d
Days
Class 2
Risk

K163121 is an FDA 510(k) clearance for the SmartUs EXT-1M/3M. 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 Telemed (Vilnius, LT). The FDA issued a Cleared decision on August 10, 2017 after a review of 275 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Telemed devices

Submission Details

510(k) Number K163121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date August 10, 2017
Days to Decision 275 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
168d slower than avg
Panel avg: 107d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 634
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K163121.
ZS3 Ultrasound System, z.one pro Ultrasound System
K171891 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2017
Acclarix AX4 Diagnostic Ultrasound System
K171900 · Edan Instruments, Inc. · Aug 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
K172374 · Siemens Medical Solutions USA, Inc. · Aug 2017
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
K171034 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · Toshibamedical Systems Corporation · May 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
K163690 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2017