Cleared Traditional

M. 1336S CATHODE-RAY TUBE DISPLAY (K780782) - FDA 510(k) Clearance

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

K780782 · Hewlett-Packard Co. · Radiology device
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Jun 1978
Decision
33d
Days
Class 2
Risk

K780782 is an FDA 510(k) clearance for the M. 1336S CATHODE-RAY TUBE DISPLAY. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2450 - 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 K780782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1978
Decision Date June 14, 1978
Days to Decision 33 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
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 23
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K780782.
SINGLE CHANNEL NON-FADE OSCILLOSCOPE
K811911 · Quinton, Inc. · Jul 1981
CRT DISPLAY #1310B
K803123 · Hewlett-Packard Co. · Jan 1981
LARGE SCREEN CRT DISPLAY #1311B
K801000 · Hewlett-Packard Co. · May 1980
MEDICAL OSCILLOSCOPE MEMORY SCOPE
K760721 · Abbott Laboratories · Oct 1976
MONITOR SCOPE
K760523 · Hewlett-Packard Co. · Sep 1976