Cleared Traditional

K162972 - ExactVu High Resolution Micro-Ultrasoun...

K162972 is an FDA 510(k) clearance for ExactVu High Resolution Micro-Ultrasoun..., manufactured by Exact Imaging. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K162972 · Exact Imaging · Radiology device
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Dec 2016
Decision
38d
Days
Class 2
Risk

K162972 is an FDA 510(k) clearance for the ExactVu High Resolution Micro-Ultrasound System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Exact Imaging (Markham, CA). The FDA issued a Cleared decision on December 2, 2016 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Exact Imaging devices

FDA 510(k) Submission Details - K162972

510(k) Number K162972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2016
Decision Date December 02, 2016
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 488
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