Cleared Traditional

K043122 - SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GR...

K043122 is an FDA 510(k) clearance for SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GR..., manufactured by Siemens AG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K043122 · Siemens AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
89d
Days
Class 2
Risk

K043122 is an FDA 510(k) clearance for the SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY. 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 AG (Lafayette, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 89 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 AG devices

FDA 510(k) Submission Details - K043122

510(k) Number K043122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date February 09, 2005
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K043122.
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
K050751 · Agfa Corp. · Apr 2005
20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)
K050485 · Totoku Electric Co., Ltd. · Apr 2005
MONOCHROME LCD MONITOR, RADIFORCE G51
K042755 · Eizo Nanao Corporation · Feb 2005
20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB
K043430 · Totoku Electric Co., Ltd. · Jan 2005
CENTRICITY PACS SYSTEM
K043415 · Ge Medical Systems Information Technologies · Jan 2005
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc. · Jan 2005