Cleared Traditional

K053458 - WEB1000

K053458 is an FDA 510(k) clearance for WEB1000, manufactured by Agfa Corp.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K053458 · Agfa Corp. · Radiology device
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Dec 2005
Decision
9d
Days
Class 2
Risk

K053458 is an FDA 510(k) clearance for the WEB1000. 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 Agfa Corp. (Waterloo, Ontario, CA). The FDA issued a Cleared decision on December 22, 2005 after a review of 9 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.

View all Agfa Corp. devices

FDA 510(k) Submission Details - K053458

510(k) Number K053458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2005
Decision Date December 22, 2005
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
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

Underwriters Laboratories, Inc.
JEFFREY D RONGERO

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 1235
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K053458.
KODAK PACS
K060055 · Eastman Kodak Company · Feb 2006
KODAK CARESTREAM PACS
K053347 · Eastman Kodak Company · Jan 2006
CAAS
K052988 · Pie Medical Imaging BV · Dec 2005
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · Vital Images, Inc. · Dec 2005
SYNGO DYNAMICS, VERSION 5.0
K053133 · Siemens Medical Solutions USA, Inc. · Dec 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · Toshiba America Medical Systems, In.C · Nov 2005