FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY

K Number: K913234 · Decision Sep 23, 1991
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
162
Applicant Total
7
Review Days
63

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Basic Information

Device Name
VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
K Number
K913234
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
892.1700
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Varian Canada, Inc.
Date Received
July 22, 1991
Decision Date
September 23, 1991
Product Code
IZO
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IZO Generator, High-Voltage, X-Ray, Diagnostic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (IZO), ordered by most recent decision date.

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Other Clearances by Varian Canada, Inc.

K Number Device Name
K953582 HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR
K923455 HFG 350, 650, 1050
K920938 VJW2919 PNEUMATIC COMPRESSION UPGRADE
K910820 VPW 2877E6 X-RAY POWER SUPPLY
K904169 VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY
K905855 VPW2877E7 X RAY POWER SUPPLY