Cleared Traditional

K140232 - SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT

K140232 is an FDA 510(k) clearance for SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOM..., 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 196-day FDA review.

K140232 · Siemens Medical Solutions USA, Inc. · Radiology device
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Aug 2014
Decision
196d
Days
Class 2
Risk

K140232 is an FDA 510(k) clearance for the SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on August 14, 2014 after a review of 196 days - an extended review cycle.

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 - K140232

510(k) Number K140232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2014
Decision Date August 14, 2014
Days to Decision 196 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
89d slower than avg
Panel avg: 107d · This submission: 196d
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 K140232.
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K140912 · Siemens Medical Solutions USA, Inc. · Sep 2014
SURESUBTRACTION LUNG
K133324 · Toshiba Medical Systems Corporation, Japan · Sep 2014
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
K134025 · Toshibamedical Systems Corporation · Sep 2014
SYNGO, CT DUAL ENERGY
K133648 · Siemens Medical Solutions USA, Inc. · Jul 2014
PARI-PATH SURGICAL NAVIGATION SYSTEM
K133901 · Paritic, Inc. · Jun 2014
ADMIRE
K133646 · Siemens Medical Systems, Inc. · Jun 2014