Cleared Traditional

K182517 - MULTIX Impact

K182517 is the FDA 510(k) clearance for MULTIX Impact by Siemens Medi Cal Solutions, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K182517 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Jan 2019
Decision
120d
Days
Class 2
Risk

K182517 is an FDA 510(k) clearance for the MULTIX Impact. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Malvern, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 120 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 Medi Cal Solutions, Inc. devices

Submission Details

510(k) Number K182517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2018
Decision Date January 11, 2019
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 164
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K182517.
Multix Fusion Max
K191418 · Siemens Medical Solutions USA, Inc. · Jun 2019
MasteRad MX30
K190601 · Medicatech USA · Apr 2019
ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
K183541 · Prognosys Medical Systems Private Limited · Jan 2019
GC70, GU60A, GU60A-65, GF50, GR50A
K182183 · Samsung Electronics Co., Ltd. · Dec 2018
ARiX RAD Radiographic System
K182134 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Nov 2018
Halifax Imaging Kit
K182880 · Halifax Biomedical, Inc. · Oct 2018