Cleared Traditional

K152949 - WebPAX

K152949 is an FDA 510(k) clearance for WebPAX, manufactured by Heart Imaging Technologies, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K152949 · Heart Imaging Technologies, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
316d
Days
Class 2
Risk

K152949 is an FDA 510(k) clearance for the WebPAX. 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 Heart Imaging Technologies, LLC (Durham, US). The FDA issued a Cleared decision on August 17, 2016 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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-to-high 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.

FDA 510(k) Submission Details - K152949

510(k) Number K152949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2015
Decision Date August 17, 2016
Days to Decision 316 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
209d slower than avg
Panel avg: 107d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 2233
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K152949.
PROcedure Rehearsal Studio
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ResolutionMD
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PACS CORE/ENCORE
K161518 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Aug 2016
5D Viewer
K161955 · Samsung Medison Co., Ltd. · Aug 2016
icobrain
K161148 · Icometrix · Aug 2016