Cleared Special

K161345 - RadPRO® Mobile 40kW (FDA 510(k) Clearance)

Also includes:
RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161345 · Sedecal., Sa. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
54d
Days
Class 2
Risk

K161345 is an FDA 510(k) clearance for the RadPRO® Mobile 40kW. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal., Sa. (Algete, ES). The FDA issued a Cleared decision on July 6, 2016 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sedecal., Sa. devices

Submission Details

510(k) Number K161345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2016
Decision Date July 06, 2016
Days to Decision 54 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 107d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 233
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