Cleared Traditional

K042203 - LEONARDO SYNGO CARDIOLOGY WORKSTATION

K042203 is an FDA 510(k) clearance for LEONARDO SYNGO CARDIOLOGY WORKSTATION, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K042203 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 2004
Decision
39d
Days
Class 2
Risk

K042203 is an FDA 510(k) clearance for the LEONARDO SYNGO CARDIOLOGY WORKSTATION. 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 September 24, 2004 after a review of 39 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K042203

510(k) Number K042203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2004
Decision Date September 24, 2004
Days to Decision 39 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1805
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042203.
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
K042525 · Ge Medical Systems Information Technologies · Oct 2004
ALLURA 3D-CA, RELEASE 1
K042334 · Philips Medical Systems North America Co. · Sep 2004
UBIPACS
K042507 · Icm Co., Ltd. · Sep 2004
ULTRASOUND CAPTURE SYSTEM
K042042 · Heartlab, Inc. · Sep 2004
PACSPARTNER
K042311 · Medical Standard Co., Ltd. · Sep 2004
INTEGRADWEB MPR/MIP
K042313 · Dynamic Imaging, Inc. · Sep 2004