Cleared Traditional

K043324 - AIDA WITH DICOM AND HL7 INTERFACE

K043324 is an FDA 510(k) clearance for AIDA WITH DICOM AND HL7 INTERFACE, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K043324 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K043324

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 131d · This submission: 123d
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 100
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K043324.
IEC MEDSIGHT AND MEDBRIGHT
K080809 · Innovative Endoscopy Components, LLC · Aug 2008
ENDOSCOPY VIDEO CAMERA SYSTEM
K081585 · Vision Systems Group, A Division of Viking Systems · Jun 2008
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc. · May 2007
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2
K041494 · Olympus Corporation · Jul 2004
KSEA OPSERVER LAP
K031895 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
VP-1000
K032544 · Mgb Endoskopische Gerate GmbH (Berlin) · Sep 2003
K043324 · AIDA WITH DICOM AND HL7 INTERFACE
Download PDF FDA Summary KARL STORZ Endoscopy-…