Cleared Traditional

K090800 - VS-100 ILLUMINATION AND IMAGING SYSTEM

K090800 is an FDA 510(k) clearance for VS-100 ILLUMINATION AND IMAGING SYSTEM, manufactured by Schoelly Imaging, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K090800 · Schoelly Imaging, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
55d
Days
Class 2
Risk

K090800 is an FDA 510(k) clearance for the VS-100 ILLUMINATION AND IMAGING SYSTEM. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Schoelly Imaging, Inc. (Framingham, US). The FDA issued a Cleared decision on May 18, 2009 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schoelly Imaging, Inc. devices

FDA 510(k) Submission Details - K090800

510(k) Number K090800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date May 18, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 58
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K090800.
IMAGE1 GI CCU MODEL 22203020-114
K111997 · KARL STORZ Endoscopy-America, Inc. · Apr 2012
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
K102466 · Fujinon, Inc. · May 2011
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
K102059 · Olympus Medical Systems Corporation · Oct 2010
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · Olympus Medical Systems Corporation · Jan 2009
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc. · May 2007
AIDA WITH DICOM AND HL7 INTERFACE
K043324 · KARL STORZ Endoscopy-America, Inc. · Apr 2005