Cleared Traditional

K182175 - TCD-X

K182175 is the FDA 510(k) clearance for TCD-X by Atys. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K182175 · Atys · Radiology device
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Apr 2019
Decision
238d
Days
Class 2
Risk

K182175 is an FDA 510(k) clearance for the TCD-X. 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 Atys (Soucieu En Jarrest, FR). The FDA issued a Cleared decision on April 5, 2019 after a review of 238 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 Atys devices

Submission Details

510(k) Number K182175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date April 05, 2019
Days to Decision 238 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
131d slower than avg
Panel avg: 107d · This submission: 238d
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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K182175.
6400 Ultrasound System (MyLabX6, MyLabX7)
K190989 · Esaote, S.P.A. · May 2019
ExactVu High Resolution Micro-Ultrasound System
K190995 · Exact Imaging, Inc. · May 2019
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
K183660 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2019
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K183377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2019
ARIETTA 50
K190248 · Hitachi Healthcare Americas · Apr 2019
7400 Ultrasound Systems
K190447 · Navigant Consulting - on Behalf of Esaote S.P.A. · Apr 2019