Cleared Traditional

K893833 - AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER

K893833 is an FDA 510(k) clearance for AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/..., manufactured by Acoustic Imaging. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K893833 · Acoustic Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
108d
Days
Class 2
Risk

K893833 is an FDA 510(k) clearance for the AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER. 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 Acoustic Imaging (Tempe, US). The FDA issued a Cleared decision on September 11, 1989 after a review of 108 days - within the typical 510(k) review window.

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 Acoustic Imaging devices

FDA 510(k) Submission Details - K893833

510(k) Number K893833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1989
Decision Date September 11, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 107d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 1145
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K893833.
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
PHASE 2 TRANSCRANIAL PROBE
K894163 · Biosound, Inc. · Sep 1989
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
K890055 · Acuson Corp. · May 1989
CAVROLAB
K882585 · Life-Tech Intl., Inc. · Mar 1989
ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER
K882737 · Acuson Corp. · Sep 1988