Cleared Traditional

K160442 - Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

K160442 is an FDA 510(k) clearance for Lucid M1 Transcranial Doppler Ultrasoun..., manufactured by Neural Analytics, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K160442 · Neural Analytics, Inc. · Radiology device
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Oct 2016
Decision
247d
Days
Class 2
Risk

K160442 is an FDA 510(k) clearance for the Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz T.... 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 Neural Analytics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 21, 2016 after a review of 247 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 Neural Analytics, Inc. devices

FDA 510(k) Submission Details - K160442

510(k) Number K160442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2016
Decision Date October 21, 2016
Days to Decision 247 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
140d slower than avg
Panel avg: 107d · This submission: 247d
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 Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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