Cleared Traditional

K142049 - MULTIX FUSION VA30 & VA40

K142049 is an FDA 510(k) clearance for MULTIX FUSION VA30 & VA40, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K142049 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 2014
Decision
143d
Days
Class 2
Risk

K142049 is an FDA 510(k) clearance for the MULTIX FUSION VA30 & VA40. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 - K142049

510(k) Number K142049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date December 18, 2014
Days to Decision 143 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
36d slower than avg
Panel avg: 107d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 264
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K142049.
Digital Diagnostic X-ray System (GC80)
K143029 · Samsung Electronics Co., Ltd. · Feb 2015
PODIATRY X-RAY SYSTEM
K133959 · Source-Ray, Inc. · Jan 2015
EOS System
K142773 · Eos Imaging · Jan 2015
X TWIN SYSTEM
K133496 · Roesys GmbH · Dec 2014
TITAN 11
K133695 · Gemss Medical Systems Co., Ltd. · Aug 2014
DURADIAGNOST
K141381 · Philips Healthcare (Suzhou) Co., Ltd. · Jun 2014