Cleared Traditional

K780332 - CATHODE RAY TUBE DISPLAY MODEL 1340A

K780332 is the FDA 510(k) clearance for CATHODE RAY TUBE DISPLAY MODEL 1340A by Hewlett-Packard Co.. It is a Class 2 Radiology device (product code DXK) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780332 · Hewlett-Packard Co. · Radiology device
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Mar 1978
Decision
22d
Days
Class 2
Risk

K780332 is an FDA 510(k) clearance for the CATHODE RAY TUBE DISPLAY MODEL 1340A. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K780332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1978
Decision Date March 22, 1978
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
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 Radiology devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 39
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K780332.
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980
ULTRA IMAGER
K800553 · Honeywell, Inc. · Jul 1980
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
HIGH-SPEED SECTOR SCANNING SSL-52H
K771292 · Toshiba Medical Systems · Aug 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755 · Honeywell, Inc. · May 1977
ECHOCARDIOGRAPHY SYS., MODEL 3860
K770756 · Honeywell, Inc. · May 1977