Cleared Traditional

K182175 - TCD-X

K182175 is an FDA 510(k) clearance for TCD-X, manufactured by Atys. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K182175

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.

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 1085
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K182175.
6400 Ultrasound System (MyLabX6, MyLabX7)
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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