Cleared Traditional

K192157 - 6450 Ultrasound system

K192157 is the FDA 510(k) clearance for 6450 Ultrasound system by Esaote, S.P.A.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K192157 · Esaote, S.P.A. · Radiology device
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Nov 2019
Decision
105d
Days
Class 2
Risk

K192157 is an FDA 510(k) clearance for the 6450 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 Esaote, S.P.A. (Genoa, IT). The FDA issued a Cleared decision on November 22, 2019 after a review of 105 days - within the typical 510(k) review window.

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 Esaote, S.P.A. devices

Submission Details

510(k) Number K192157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date November 22, 2019
Days to Decision 105 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
2d faster than avg
Panel avg: 107d · This submission: 105d
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 786
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K192157.
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System
K192152 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2019
HS50/HS60 Diagnostics Ultrasound System
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K192835 · Siemens Medical Solutions USA, Inc. · Oct 2019
ExactVu High Resolution Micro-Ultrasound System
K192303 · Exact Imaging, Inc. · Oct 2019