Cleared Traditional

ULTRA IMAGER (K800553) - FDA 510(k) Clearance

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

K800553 · Honeywell, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 K800553.
SONOLINE SX ULTRASOUND SCANNER
K852739 · Siemens Medical Solutions USA, Inc. · Mar 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978