Cleared Traditional

K902106 - VPW 2877D5, X-RAY POWER SUPPLY

K902106 is an FDA 510(k) clearance for VPW 2877D5, manufactured by Varian Assoc., Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K902106 · Varian Assoc., Inc. · Radiology device
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Aug 1990
Decision
94d
Days
Class 1
Risk

K902106 is an FDA 510(k) clearance for the VPW 2877D5, X-RAY POWER SUPPLY. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 10, 1990 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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

FDA 510(k) Submission Details - K902106

510(k) Number K902106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date August 10, 1990
Days to Decision 94 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 faster than avg
Panel avg: 107d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K902106.
ANATECH X-RAY GENERATOR
K904114 · Continental X-Ray Corp. · Jan 1991
KXO-80C/80D
K904043 · Toshiba America Medical Systems, In.C · Nov 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G
K903942 · Shimadzu Medical Systems · Oct 1990
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479 · Bennett X-Ray Corp. · Sep 1989
RME 325R
K893674 · Fischer Imaging Corp. · Jul 1989
MULTI PULSE POWER UNIT GENERATOR
K892943 · GE Medical Systems · May 1989