Cleared Traditional

K162055 - Acclarix LX8 Diagnostic Ultrasound System

K162055 is an FDA 510(k) clearance for Acclarix LX8 Diagnostic Ultrasound System, manufactured by Edan Instruments, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K162055 · Edan Instruments, Inc. · Radiology device
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Jan 2017
Decision
190d
Days
Class 2
Risk

K162055 is an FDA 510(k) clearance for the Acclarix LX8 Diagnostic Ultrasound System. 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 Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 31, 2017 after a review of 190 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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K162055

510(k) Number K162055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date January 31, 2017
Days to Decision 190 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
83d slower than avg
Panel avg: 107d · This submission: 190d
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 Consultant

Edan Medical
Doug Worth

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 - 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 K162055.
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
K163688 · Medisono, LLC · Feb 2017
HS70A Diagnostic Ultrasound System
K163691 · Samsung Medison Co., Ltd. · Feb 2017
LOGIQ P9 and LOGIQ P7
K163596 · Ge Healthcare · Feb 2017
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
K163635 · Siemens Medical Solutions USA, Inc. Ultrasound Group · Jan 2017
EPIQ 5 Diagnostic Ultrasound System
K163120 · Philips Ultrasound, Inc. · Jan 2017
ACUSON P500 Ultrasound System
K163396 · Siemens Medical Solutions USA, Inc. · Jan 2017