Cleared Special

K001140 - IDS5 IMAGE DISPLAY SYSTEM

K001140 is an FDA 510(k) clearance for IDS5 IMAGE DISPLAY SYSTEM, manufactured by Sectra AB. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 23-day FDA review.

K001140 · Sectra AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
23d
Days
Class 2
Risk

K001140 is an FDA 510(k) clearance for the 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 AB (Aubrey, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 23 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 AB devices

FDA 510(k) Submission Details - K001140

510(k) Number K001140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date May 03, 2000
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
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 1204
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K001140.
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C · Oct 2000
VITREA 2, VERSION 2.1
K002519 · Vital Images, Inc. · Oct 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · Advanced Technology Laboratories, Inc. · Sep 2000
VIEW NT
K000474 · Electromed Intl., Ltd. · Apr 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · Barco N.V. · Mar 2000
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
K000293 · Barco N.V. · Mar 2000