Cleared Special

IDS5 IMAGE DISPLAY SYSTEM (K001140) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K001140 · Sectra AB · Radiology device
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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

Submission Details

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.

Device Classification

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 803
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K001140.
SYNGO MULTIMODALITY WORKSTATION
K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001
ODYSSEY LX, MODEL 211320
K003437 · Philips Medical Systems (Cleveland), Inc. · Feb 2001
3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
K002424 · Toshiba America Medical Systems, In.C · Oct 2000
INTURIS SUITE
K994210 · Philips Medical Systems, Inc. · Feb 2000
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
K992886 · Toshiba America Medical Systems, In.C · Nov 1999
AX WORKSTATION
K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999