Cleared Traditional

RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER (K883845) - FDA 510(k) Clearance

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

K883845 · Phoenix Imaging · Cardiovascular device
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Feb 1989
Decision
144d
Days
Class 2
Risk

K883845 is an FDA 510(k) clearance for the RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Phoenix Imaging (Tempe, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - the FDA cardiovascular device 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Phoenix Imaging devices

Submission Details

510(k) Number K883845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1988
Decision Date February 03, 1989
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 14
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K883845.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173 · Boston Scientific Corporation · Feb 2016
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co. · Mar 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988