Cleared Special

K152316 - iLab Ultrasound Imaging System

K152316 is an FDA 510(k) clearance for iLab Ultrasound Imaging System, manufactured by Boston Scientific. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 32-day FDA review.

K152316 · Boston Scientific · Radiology device
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Sep 2015
Decision
32d
Days
Class 2
Risk

K152316 is an FDA 510(k) clearance for the iLab Ultrasound Imaging System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Boston Scientific (Fremont, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific devices

FDA 510(k) Submission Details - K152316

510(k) Number K152316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2015
Decision Date September 18, 2015
Days to Decision 32 days
Submission Type Special
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
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 652
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