Cleared Abbreviated

K032748 - VITREA2

K032748 is the FDA 510(k) clearance for VITREA2 by Vital Images, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Abbreviated 510(k) pathway after a 54-day FDA review.

K032748 · Vital Images, Inc. · Radiology device
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Oct 2003
Decision
54d
Days
Class 2
Risk

K032748 is an FDA 510(k) clearance for the VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE. 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 Vital Images, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 54 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. 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 Vital Images, Inc. devices

Submission Details

510(k) Number K032748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date October 29, 2003
Days to Decision 54 days
Submission Type Abbreviated
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
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Standards-based clearance path.

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 1055
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K032748.
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · Adac Laboratories · Feb 2004
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
HOLOGIC DR IMAGEPRO
K032546 · Hologic, Inc. · Oct 2003
PHILIPS VIEWFORUM 2003
K032096 · Philips Medical Systems · Jul 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003