Cleared Special

K160001 - TraumaCad Mobile Release 2.0

K160001 is an FDA 510(k) clearance for TraumaCad Mobile Release 2.0, manufactured by Voyant Health, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 39-day FDA review.

K160001 · Voyant Health, Ltd. · Radiology device
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Feb 2016
Decision
39d
Days
Class 2
Risk

K160001 is an FDA 510(k) clearance for the TraumaCad Mobile Release 2.0. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Voyant Health, Ltd. (Petach-Tikva, IL). The FDA issued a Cleared decision on February 12, 2016 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Voyant Health, Ltd. devices

FDA 510(k) Submission Details - K160001

510(k) Number K160001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2016
Decision Date February 12, 2016
Days to Decision 39 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

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