Cleared Special

K033088 - SECTRA IDS5 RADIOLOGY WORKSTATION VERSI...

K033088 is an FDA 510(k) clearance for SECTRA IDS5 RADIOLOGY WORKSTATION VERSI..., 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 30-day FDA review.

K033088 · Sectra AB · Radiology device
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Oct 2003
Decision
30d
Days
Class 2
Risk

K033088 is an FDA 510(k) clearance for the SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1. 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 (Denton, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 30 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 - K033088

510(k) Number K033088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date October 29, 2003
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K033088.
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
LCD MONITOR, RADIFORCE G11, G31, G51
K032026 · Eizo Nanao Corporation · Aug 2003
PHILIPS FRESCO RELEASE 1
K031836 · Philips Medical Systems North America Co. · Aug 2003