Cleared Special

SECTRA WORKSTATION, VERSION 11.1 (K063093) - FDA 510(k) Clearance

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

K063093 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (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.

View all Sectra-Imtec AB devices

Submission Details

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
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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 737
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063093.
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007
SYNGO DYNAMICS, VERSION 6.0
K070322 · Siemens Medical Solutions USA, Inc. · Feb 2007
SYNGO MI APPLICATIONS 2007A
K063826 · Siemens Medical Solutions USA, Inc. · Jan 2007
GE LOGIQ WORKS
K063006 · General Electric Co. · Nov 2006
KODAK PACS
K060055 · Eastman Kodak Company · Feb 2006
KODAK CARESTREAM PACS
K053347 · Eastman Kodak Company · Jan 2006