Cleared Special

K063826 - SYNGO MI APPLICATIONS 2007A

K063826 is the FDA 510(k) clearance for SYNGO MI APPLICATIONS 2007A 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 17-day FDA review.

K063826 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jan 2007
Decision
17d
Days
Class 2
Risk

K063826 is an FDA 510(k) clearance for the SYNGO MI APPLICATIONS 2007A. 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. (Hoffman Estates, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 17 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 K063826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date January 12, 2007
Days to Decision 17 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
90d faster than avg
Panel avg: 107d · This submission: 17d
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

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