Cleared Special

K033013 - MDIFICATION TO MEDIPRIME

K033013 is an FDA 510(k) clearance for MDIFICATION TO MEDIPRIME, manufactured by Algotec Systems, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 60-day FDA review.

K033013 · Algotec Systems, Ltd. · Radiology device
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Nov 2003
Decision
60d
Days
Class 2
Risk

K033013 is an FDA 510(k) clearance for the MDIFICATION TO MEDIPRIME. 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 Algotec Systems, Ltd. (Efrat, IL). The FDA issued a Cleared decision on November 25, 2003 after a review of 60 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.

View all Algotec Systems, Ltd. devices

FDA 510(k) Submission Details - K033013

510(k) Number K033013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date November 25, 2003
Days to Decision 60 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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 1330
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033013.
SIENET COSMOS
K033831 · Siemens AG Medical Solutions · Dec 2003
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · Vital Images, Inc. · Oct 2003
HOLOGIC DR IMAGEPRO
K032546 · Hologic, Inc. · Oct 2003
WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
K032960 · Wide Corporation · Oct 2003