Cleared Traditional

K180583 - LOGIC 4K CAMERA CONTROLLER

K180583 is an FDA 510(k) clearance for LOGIC 4K CAMERA CONTROLLER, manufactured by Richard Wolf Medical Instruments Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K180583 · Richard Wolf Medical Instruments Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
115d
Days
Class 2
Risk

K180583 is an FDA 510(k) clearance for the LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corporation (Vernon Hills, US). The FDA issued a Cleared decision on June 28, 2018 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corporation devices

FDA 510(k) Submission Details - K180583

510(k) Number K180583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date June 28, 2018
Days to Decision 115 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 130d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FET Device Classification - Class 2, Special Controls

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 61
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K180583.
Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
K190449 · Olympus Medical Systems Corp. · Aug 2019
Pusen Eview Medical Video Endoscope Image Processor
K190648 · Zhuhai Pusen Medical Technology Co., Ltd. · Mar 2019
Telepack X LED
K182696 · KARL STORZ Endoscopy-America, Inc. · Nov 2018
EPX-4440FN Digital Video Processor with Light Source
K180414 · Fujifilm New Development U.S.A., Inc. · May 2018
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
K172817 · Olympus Medical Systems Corp. · Oct 2017
Processor VP-7000, Light Source BL-7000
K163675 · Fujifilm Medical System U.S.A., Inc. · Apr 2017