Cleared Special

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (K171755) - FDA 510(k) Clearance

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

K171755 · Omega Medical Imaging, LLC · Radiology device
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Feb 2018
Decision
241d
Days
Class 2
Risk

K171755 is an FDA 510(k) clearance for the CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy .... Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on February 9, 2018 after a review of 241 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omega Medical Imaging, LLC devices

Submission Details

510(k) Number K171755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2017
Decision Date February 09, 2018
Days to Decision 241 days
Submission Type Special
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
134d slower than avg
Panel avg: 107d · This submission: 241d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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.

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