Cleared Special

K081469 - SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2

K081469 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 16-day FDA review.

K081469 · Sectra-Imtec AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
16d
Days
Class 2
Risk

K081469 is an FDA 510(k) clearance for the SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2. 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 June 12, 2008 after a review of 16 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 - K081469

510(k) Number K081469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date June 12, 2008
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
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 K081469.
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · Aloka Co., Ltd. · Jul 2008
SYNGO IMAGING (VERSION V31)
K081734 · Siemens AG Medical Solutions · Jul 2008
DC NEURO
K081262 · Invivo Corporation · Jun 2008
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
K081055 · Totoku Electric Co., Ltd. · Jun 2008
21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
K081056 · Totoku Electric Co., Ltd. · Jun 2008
FUJIFILM FCR VIEW, MODEL CR-VW674
K081308 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2008