Cleared Traditional

K180636 - ExactVu High Resolution Micro-Ultrasoun...

K180636 is the FDA 510(k) clearance for ExactVu High Resolution Micro-Ultrasoun... by Exact Imaging, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K180636 · Exact Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
49d
Days
Class 2
Risk

K180636 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, Inc. (Markham, CA). The FDA issued a Cleared decision on April 30, 2018 after a review of 49 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, Inc. devices

Submission Details

510(k) Number K180636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date April 30, 2018
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 387
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K180636.
Uscan
K181574 · EchoNous, Inc. · Jul 2018
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
K181547 · Echosens · Jul 2018
Shear Wave Quantificational Ultrasound Diagnostic System
K173595 · Wuxi Hisky Medical Technologies Co., Ltd. · Jun 2018
LIGHTSonic BUBM
K170761 · Lightmed USA, Inc. · Apr 2018
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
K173860 · Volcano Corporation · Apr 2018
SoftVue
K172256 · Delphinus Medical Technologies · Mar 2018