Cleared Special

K023936 - MODIFICATION TO MEDIPRIME

K023936 is an FDA 510(k) clearance for MODIFICATION 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 24-day FDA review.

K023936 · Algotec Systems, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
24d
Days
Class 2
Risk

K023936 is an FDA 510(k) clearance for the MODIFICATION 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 December 20, 2002 after a review of 24 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 - K023936

510(k) Number K023936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date December 20, 2002
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 K023936.
CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023340 · Barco N.V. · Dec 2002
CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K023341 · Barco N.V. · Dec 2002
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
K023877 · Philips Ultrasound, Inc. · Dec 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · Philips Medical Systems North America Co. · Dec 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K022773 · Barco N.V. · Dec 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · Acuson Corp. · Nov 2002