Cleared Traditional

K802434 - VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH

K802434 is the FDA 510(k) clearance for VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K802434 · Varian Assoc., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
136d
Days
Class 2
Risk

K802434 is an FDA 510(k) clearance for the VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 136 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K802434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1980
Decision Date February 19, 1981
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 K802434.
5CM SMALL PARTS SCANNER
K810914 · Smithkline Diagnostics, Inc. · May 1981
OPHTHALMO ECHOGRAPH MODEL ZD255G
K802635 · Jedmed Instrument Co. · Apr 1981
MARK 500 SYSTEM
K810073 · Advanced Technology Laboratories, Inc. · Mar 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802437 · Advanced Technology Laboratories, Inc. · Jan 1981
DATASON RTL II
K802695 · General Electric Co. · Jan 1981
SYSTEM, ECHO, PULSED ULTRASONIC DIAG.
K802708 · General Electric Co. · Jan 1981