Cleared Traditional

K043324 - AIDA WITH DICOM AND HL7 INTERFACE (FDA 510(k) Clearance)

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

K043324 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
123d
Days
Class 2
Risk

K043324 is an FDA 510(k) clearance for the AIDA WITH DICOM AND HL7 INTERFACE. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 4, 2005 after a review of 123 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K043324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date April 04, 2005
Days to Decision 123 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 130d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 97
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K043324.
ProVee Video Processing Unit (PV-003)
K251734 · Proverum Limited · Sep 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462 · Univlabs Technologies Private Limited · Aug 2025
Endoscopic Camera System
K250204 · Shenzhen Sophway Technology Co., Ltd. · Jul 2025
FUJIFILM Processor EP-8000
K243260 · Fujifilm Corporation · Apr 2025
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
K242067 · Olympus Corporations of the Americas · Apr 2025
Endoscopic Video Image Processor (RP-IPD-V1000F)
K243321 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Feb 2025