Cleared Traditional

K100363 - ULTRA DCI MODEL 5000

K100363 is an FDA 510(k) clearance for ULTRA DCI MODEL 5000, manufactured by Ultrasound Medical Devices, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K100363 · Ultrasound Medical Devices, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
98d
Days
Class 2
Risk

K100363 is an FDA 510(k) clearance for the ULTRA DCI MODEL 5000. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Ultrasound Medical Devices, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Ultrasound Medical Devices, Inc. devices

FDA 510(k) Submission Details - K100363

510(k) Number K100363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date May 21, 2010
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 517
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K100363.
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K102991 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2010
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
K101337 · Sonoscape Company Limited · Sep 2010
HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
K093466 · Hitachi Medical Systems America, Inc. · Jun 2010
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
K093488 · Aloka Co., Ltd. · Nov 2009
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
K082229 · Volcano Corporation · Oct 2008
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
K080234 · Teratech Corp. · Feb 2008