Cleared Traditional

K904359 - ESI-3000 ULTRASOUND SYSTEM

K904359 is the FDA 510(k) clearance for ESI-3000 ULTRASOUND SYSTEM by Elscint, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K904359 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
162d
Days
Class 2
Risk

K904359 is an FDA 510(k) clearance for the ESI-3000 ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 162 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Elscint, Inc. devices

Submission Details

510(k) Number K904359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date March 05, 1991
Days to Decision 162 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 107d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 793
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K904359.
DIAGNOSTIC ULTRASOUND SYSTEM
K915403 · Hitachi Medical Systems America, Inc. · May 1994
ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION
K940285 · Acuson Corp. · Apr 1994
SSH-140A FETAL DOPPLER SYSTEM
K931293 · Toshiba America Medical Systems, In.C · Feb 1994
DOPPLER OPTION FOR PLATINUM
K902691 · Philips Medical Systems, Inc. · Jan 1991
CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM
K901329 · Advanced Technology Laboratories, Inc. · Nov 1990
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K894054 · Advanced Technology Laboratories, Inc. · Sep 1989