Cleared Traditional

ECHO TRUE 3D VIEWER (K142107) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142107 · Echopixel, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
173d
Days
Class 2
Risk

K142107 is an FDA 510(k) clearance for the ECHO TRUE 3D VIEWER. 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 Echopixel, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 21, 2015 after a review of 173 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. 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 Echopixel, Inc. devices

Submission Details

510(k) Number K142107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date January 21, 2015
Days to Decision 173 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
66d slower than avg
Panel avg: 107d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

All 2268
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K142107.
CustoMED Viewer
K260116 · CustoMED , Ltd. · Jun 2026
Helion Viewer Suite
K254265 · Videomed Srl ( a Baxter Healthcare Corp company) · May 2026
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
K253831 · Cercare Medical A/S · May 2026
SubtleHD-PET (1.x)
K254013 · Subtle Medical, Inc. · May 2026
HipGuide (V 1.0.0.0)
K260321 · Orthopedic Driven Imaging, LLC · May 2026
Neowise
K260716 · Cefla S.C. · May 2026