Cleared Traditional

K132934 - MULTIX SELECT DR

K132934 is an FDA 510(k) clearance for MULTIX SELECT DR, manufactured by Siemens Medi Cal Solutions, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K132934 · Siemens Medi Cal Solutions, Inc. · Radiology device
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Apr 2014
Decision
204d
Days
Class 2
Risk

K132934 is an FDA 510(k) clearance for the MULTIX SELECT DR. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Siemens Medi Cal Solutions, Inc. (Mavern, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 204 days - an extended review cycle.

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

FDA 510(k) Submission Details - K132934

510(k) Number K132934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date April 10, 2014
Days to Decision 204 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
97d slower than avg
Panel avg: 107d · This submission: 204d
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 270
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K132934.
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