Cleared Traditional

K182834 - CS-series-FP with Optional ROI Accessor...

K182834 is an FDA 510(k) clearance for CS-series-FP with Optional ROI Accessor..., manufactured by Omega Medical Imaging, LLC. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K182834 · Omega Medical Imaging, LLC · Radiology device
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Mar 2019
Decision
171d
Days
Class 2
Risk

K182834 is an FDA 510(k) clearance for the CS-series-FP with Optional ROI Accessory CA-100S. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 171 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. 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 Omega Medical Imaging, LLC devices

FDA 510(k) Submission Details - K182834

510(k) Number K182834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date March 29, 2019
Days to Decision 171 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
64d slower than avg
Panel avg: 107d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

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