Cleared Special

K063093 - SECTRA WORKSTATION, VERSION 11.1

K063093 is an FDA 510(k) clearance for SECTRA WORKSTATION, 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 28-day FDA review.

K063093 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
28d
Days
Class 2
Risk

K063093 is an FDA 510(k) clearance for the SECTRA WORKSTATION, VERSION 11.1. 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 November 7, 2006 after a review of 28 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.

FDA 510(k) Submission Details - K063093

510(k) Number K063093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date November 07, 2006
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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 2257
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063093.
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
K063266 · Chi Lin Technology Co., Ltd. · Nov 2006
ISITE PACS, V 4. X
K063267 · Stentor Inc., A Philips Medical Systems Co. · Nov 2006
XERON PACS
K062757 · Xeron Healthcare Corp. · Nov 2006
GE LOGIQ WORKS
K063006 · General Electric Co. · Nov 2006
PRISM VIEW, MODEL
K063031 · Kyron Clinical Imaging, Inc. · Nov 2006
IMT.LAB SOFTWARE
K062598 · Esaote Europe B.V. · Oct 2006
K063093 · SECTRA WORKSTATION, VERSION 11.1
Download PDF FDA Summary Sectra-Imtec AB