Cleared Traditional

K143409 - SOMATOM Definition AS Open (VA48)

K143409 is an FDA 510(k) clearance for SOMATOM Definition AS Open (VA48), manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K143409 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
118d
Days
Class 2
Risk

K143409 is an FDA 510(k) clearance for the SOMATOM Definition AS Open (VA48). Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K143409

510(k) Number K143409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date March 26, 2015
Days to Decision 118 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
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 722
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K143409.
SOMATOM Definition Flash (VA48)
K143416 · Siemens Medical Solutions USA, Inc. · Apr 2015
SOMATOM Definition AS/AS+
K143400 · Siemens Medical Solutions USA, Inc. · Apr 2015
SOMATOM Definition Edge
K143401 · Siemens Medical Solutions USA, Inc. · Apr 2015
Aquilion LB, TSX-201A/3, V6.0
K150003 · Toshibamedical Systems Corporation · Mar 2015
Aquilion ONE Vision, v7.0
K142465 · Toshibamedical Systems Corporation · Mar 2015
NewTom 5G
K142222 · Qr S.R.L. · Jan 2015