Cleared Special

K002936 - MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM

K002936 is an FDA 510(k) clearance for MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM, manufactured by Sectra-Imtec AB. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K002936 · Sectra-Imtec AB · Radiology device
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Oct 2000
Decision
26d
Days
Class 2
Risk

K002936 is an FDA 510(k) clearance for the MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM. 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 Sectra-Imtec AB (Aubrey, US). The FDA issued a Cleared decision on October 17, 2000 after a review of 26 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 Sectra-Imtec AB devices

FDA 510(k) Submission Details - K002936

510(k) Number K002936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2000
Decision Date October 17, 2000
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
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 1307
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