Cleared Traditional

K910820 - VPW 2877E6 X-RAY POWER SUPPLY

K910820 is an FDA 510(k) clearance for VPW 2877E6 X-RAY POWER SUPPLY, manufactured by Varian Canada, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K910820 · Varian Canada, Inc. · Radiology device
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Mar 1991
Decision
10d
Days
Class 1
Risk

K910820 is an FDA 510(k) clearance for the VPW 2877E6 X-RAY POWER SUPPLY. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Varian Canada, Inc. (Canada L7g 2j4, CA). The FDA issued a Cleared decision on March 7, 1991 after a review of 10 days - a notably fast clearance cycle.

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: 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 Varian Canada, Inc. devices

FDA 510(k) Submission Details - K910820

510(k) Number K910820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date March 07, 1991
Days to Decision 10 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 107d · This submission: 10d
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 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K910820.
MICRO-X 15 HF
K912449 · Fischer Imaging Corp. · Aug 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K911280 · Shimadzu Medical Systems · Jun 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K
K911339 · Shimadzu Medical Systems · Apr 1991
MICRO-X 80HF
K905695 · Fischer Imaging Corp. · Mar 1991
HFQ SERIES CONTROLS AND GENERATORS
K905799 · Bennett X-Ray Corp. · Feb 1991
ANATECH X-RAY GENERATOR
K904114 · Continental X-Ray Corp. · Jan 1991