Cleared Abbreviated

K152467 - Touch Ultrasound

K152467 is an FDA 510(k) clearance for Touch Ultrasound, manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Abbreviated 510(k) pathway after a 100-day FDA review.

K152467 · Carestream Health, Inc. · Radiology device
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Dec 2015
Decision
100d
Days
Class 2
Risk

K152467 is an FDA 510(k) clearance for the Touch Ultrasound. 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 Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 9, 2015 after a review of 100 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Carestream Health, Inc. devices

FDA 510(k) Submission Details - K152467

510(k) Number K152467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2015
Decision Date December 09, 2015
Days to Decision 100 days
Submission Type Abbreviated
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
7d faster than avg
Panel avg: 107d · This submission: 100d
Pathway characteristics
Standards-based clearance path.

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 1098
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K152467.
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Venue 50
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