510(k) K913234

VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY by Varian Canada, Inc. — Product Code IZO

K913234 is an FDA 510(k) premarket notification submitted by Varian Canada, Inc. for the device "VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Varian Canada, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
July 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type