Cleared Traditional

K090119 - SICAT IMPLANT

K090119 is the FDA 510(k) clearance for SICAT IMPLANT by Sicat GmbH & Co. KG. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K090119 · Sicat GmbH & Co. KG · Radiology device
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Feb 2009
Decision
15d
Days
Class 2
Risk

K090119 is an FDA 510(k) clearance for the SICAT IMPLANT. 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 Sicat GmbH & Co. KG (Bonn, DE). The FDA issued a Cleared decision on February 5, 2009 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. 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 Sicat GmbH & Co. KG devices

Submission Details

510(k) Number K090119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date February 05, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1057
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K090119.
BARCO 5MP MAMMO, MODEL MDMG-5221
K090603 · Barco N.V. · Apr 2009
NIO COLOR 3MP AND MDNC-3121
K090732 · Barco N.V. · Apr 2009
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V. · Feb 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · Carestream Health, Inc. · Dec 2008
4D VIEWER RADIOLOGY, MODEL USWP-100A
K082684 · Toshiba America Medical Systems, In.C · Oct 2008