Cleared Traditional

K112251 - SWISSMEDA DENTAL PLANNING SYSTEM

K112251 is an FDA 510(k) clearance for SWISSMEDA DENTAL PLANNING SYSTEM, manufactured by Swissmeda AG. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K112251 · Swissmeda AG · Radiology device
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Jan 2012
Decision
173d
Days
Class 2
Risk

K112251 is an FDA 510(k) clearance for the SWISSMEDA DENTAL PLANNING SYSTEM. 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 Swissmeda AG (Zurich, CH). The FDA issued a Cleared decision on January 25, 2012 after a review of 173 days - an extended review 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 Swissmeda AG devices

FDA 510(k) Submission Details - K112251

510(k) Number K112251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2011
Decision Date January 25, 2012
Days to Decision 173 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
66d slower than avg
Panel avg: 107d · This submission: 173d
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 1276
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