Cleared Special

K012155 - KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS

K012155 is an FDA 510(k) clearance for KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ..., manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 30-day FDA review.

K012155 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
30d
Days
Class 2
Risk

K012155 is an FDA 510(k) clearance for the KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS. 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 Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 10, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 - K012155

510(k) Number K012155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date August 10, 2001
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K012155.
AETMED IMAGE PROCESSING SOFTWARE
K012093 · Aetmed, S.P.A. · Sep 2001
AQUARIUSNET SERVER
K012086 · Terarecon,Inc. · Sep 2001
VIEWSTATION
K011694 · Impac Medical Systems, Inc. · Aug 2001
QCU ANALYTICAL SOFTWARE PACKAGE
K011582 · Medis Medical Imaging Systems BV · Jul 2001
MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES
K012099 · Totoku Electric Co., Ltd. · Jul 2001
EFILM WORKSTATION
K012211 · Efilm Medical, Inc. · Jul 2001
K012155 · KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
Download PDF FDA Summary Eastman Kodak Company