510(k) K904169

VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY by Varian Canada, Inc. — Product Code IZO

K904169 is an FDA 510(k) premarket notification submitted by Varian Canada, Inc. for the device "VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY". The FDA issued a decision of Substantially Equivalent on February 19, 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
February 19, 1991
Date Received
September 11, 1990
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