Cleared Special

K033712 - MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1

K033712 is an FDA 510(k) clearance for MODIFICATION TO SECTRA IDS5 RADIOLOGY W..., 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 27-day FDA review.

K033712 · Sectra-Imtec AB · Radiology device
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Dec 2003
Decision
27d
Days
Class 2
Risk

K033712 is an FDA 510(k) clearance for the MODIFICATION TO 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-Imtec AB (Denton, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 27 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 - K033712

510(k) Number K033712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date December 23, 2003
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K033712.
INTEGRIS 3D-RA, RELEASE 4.2
K040254 · Philips Medical Systems North America Co. · Feb 2004
ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE
K040142 · Adac Laboratories · Feb 2004
CHASE CARDIAC ANALYSIS SYSTEM
K032531 · Chase Medical, Inc. · Feb 2004
SIENET COSMOS
K033831 · Siemens AG Medical Solutions · Dec 2003
PACS SOFTWARE SOLUTION 2003
K033624 · Canon USA, Inc. · Dec 2003
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003