Cleared Traditional

K890963 - SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 (FDA 510(k) Clearance)

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

K890963 · Esaote Biomedica Elettronica · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
142d
Days
Class 2
Risk

K890963 is an FDA 510(k) clearance for the SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Esaote Biomedica Elettronica (Cambridge, US). The FDA issued a Cleared decision on July 19, 1989 after a review of 142 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 Esaote Biomedica Elettronica devices

Submission Details

510(k) Number K890963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date July 19, 1989
Days to Decision 142 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 891
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K890963.
EdgeFlow UW20
K252237 · Edgecare, Inc. · Apr 2026
Accuro XV
K254021 · Rivanna Medical, Inc. · Apr 2026
QT Scanner 2000 Model A
K253898 · QT Imaging Holdings, Inc. · Mar 2026
IntraSight Plus
K253714 · Philips Image Guided Therapy Corporation · Feb 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · Eieling Technology (Shenzhen) Limited · Feb 2026
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · Astrasono Technology Co., Ltd. · Sep 2025