Cleared Traditional

CS-series-FP with Optional ROI Accessory CA-100S (K182834) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182834 · Omega Medical Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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

All 73
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K182834.
PowerDR
K191504 · Radiology Information Systems, Inc. · Aug 2019
FLUOROspeed
K191877 · Shimadzu Corporation · Aug 2019
Insight Essentials DRF Digital Imaging System
K191310 · Imaging Engineering, LLC · Jun 2019
SonialVision G4
K190373 · Shimadzu Corporation · Mar 2019
MECALL CLISIS SYSTEMS, Discovery RF180
K173395 · General Medical Merate S.P.A · May 2018
Uroview FD II
K180651 · Pausch Medical GmbH · Apr 2018