Cleared Traditional

K042008 - ULTRAVISUAL

K042008 is an FDA 510(k) clearance for ULTRAVISUAL, manufactured by Emageon Uv, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K042008 · Emageon Uv, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
39d
Days
Class 2
Risk

K042008 is an FDA 510(k) clearance for the ULTRAVISUAL. 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 Emageon Uv, Inc. (Madison, US). The FDA issued a Cleared decision on September 3, 2004 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. 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.

FDA 510(k) Submission Details - K042008

510(k) Number K042008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2004
Decision Date September 03, 2004
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042008.
PACSPARTNER
K042311 · Medical Standard Co., Ltd. · Sep 2004
INTEGRADWEB MPR/MIP
K042313 · Dynamic Imaging, Inc. · Sep 2004
ISITE PACS
K042292 · Stentor, Inc. · Sep 2004
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM
K041508 · Barco NV Barcoview · Aug 2004
SEEMOR 5.0 IMAGE DISPLAY PROGRAM
K041782 · Areeda Assoc., Ltd. · Aug 2004
DR SYSTEMS PACS, RELEASE 6.1
K041935 · Dr Systems, Inc. · Aug 2004
K042008 · ULTRAVISUAL
Download PDF FDA Summary Emageon Uv, Inc.