Cleared Special

K042995 - X-LEONARDO

K042995 is the FDA 510(k) clearance for X-LEONARDO by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 23-day FDA review.

K042995 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
23d
Days
Class 2
Risk

K042995 is an FDA 510(k) clearance for the X-LEONARDO. 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 Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 23 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K042995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date November 24, 2004
Days to Decision 23 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
84d faster than avg
Panel avg: 107d · This submission: 23d
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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042995.
CENTRICITY PACS SYSTEM
K043415 · Ge Medical Systems Information Technologies · Jan 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc. · Jan 2005
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · Vital Images, Inc. · Dec 2004
PHILIPS ORTHOPAEDIC APPLICATIONS
K042867 · Philips Medical Systems North America, Inc. · Nov 2004
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
K042525 · Ge Medical Systems Information Technologies · Oct 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc. · Sep 2004