Cleared Traditional

MODIFICATION TO ENCOMPASS (K040896) - FDA 510(k) Clearance

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

K040896 · Heartlab, Inc. · Radiology device
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Jul 2004
Decision
101d
Days
Class 2
Risk

K040896 is an FDA 510(k) clearance for the MODIFICATION TO ENCOMPASS. 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 Heartlab, Inc. (Westerly, US). The FDA issued a Cleared decision on July 16, 2004 after a review of 101 days - within the typical 510(k) review window.

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 Heartlab, Inc. devices

Submission Details

510(k) Number K040896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2004
Decision Date July 16, 2004
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 757
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K040896.
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc. · Nov 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc. · Sep 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
K030982 · Siemens Medical Solutions USA, Inc. · Apr 2003