Cleared Traditional

VPW 2877D5, X-RAY POWER SUPPLY

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

About This 510(k) Submission

K902106 is an FDA 510(k) clearance for the VPW 2877D5, X-RAY POWER SUPPLY, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 10, 1990, 94 days after receiving the submission on May 8, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K902106 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1990
Decision Date August 10, 1990
Days to Decision 94 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZO — Generator, High-voltage, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1700

Similar Devices — IZO Generator, High-voltage, X-ray, Diagnostic

All 162
MPH50, MPH65, AND MPH80
K954666 · GE Medical Systems · Nov 1995
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
K953582 · Varian Canada, Inc. · Sep 1995
N 800 HF
K953831 · Nucletron-Oldelft Corp. · Sep 1995
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
K952822 · Shimadzu Corp. · Jul 1995
MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
K952265 · Control-X, Inc. · Jul 1995
POLYDOROS SX 65 AND 80
K950883 · Siemens Medical Solutions USA, Inc. · Apr 1995