Cleared Traditional

K801954 - HP MODEL 77020A ULTRASOUND SYSTEM

K801954 is the FDA 510(k) clearance for HP MODEL 77020A ULTRASOUND SYSTEM by Hewlett-Packard Co.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K801954 · Hewlett-Packard Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
120d
Days
Class 2
Risk

K801954 is an FDA 510(k) clearance for the HP MODEL 77020A ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K801954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1980
Decision Date December 16, 1980
Days to Decision 120 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
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 423
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K801954.
DATASON RTL II
K802695 · General Electric Co. · Jan 1981
SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
K802708 · General Electric Co. · Jan 1981
SIEMENS PHO/SONIC ALPHA 1000
K802759 · Siemens Gammasonics, Inc. · Jan 1981
DATASON DB SYSTEM
K801986 · General Electric Co. · Nov 1980
MINIVISOR TERMINAL
K802263 · Organon Teknika Corp. · Oct 1980
AQUASONIC 100 ULTRASOUND TRANS. GEL,
K802146 · Parker Laboratories, Inc. · Oct 1980