Cleared Traditional

K800553 - ULTRA IMAGER

K800553 is an FDA 510(k) clearance for ULTRA IMAGER, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K800553 · Honeywell, Inc. · Cardiovascular device
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Jul 1980
Decision
132d
Days
Class 2
Risk

K800553 is an FDA 510(k) clearance for the ULTRA IMAGER. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 132 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Honeywell, Inc. devices

FDA 510(k) Submission Details - K800553

510(k) Number K800553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1980
Decision Date July 21, 1980
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K800553.
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980
U.I. OCTOSON
K802030 · Ausonics Pty , Ltd. · Oct 1980
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978
HIGH-SPEED SECTOR SCANNING SSL-52H
K771292 · Toshiba Medical Systems · Aug 1977