FDA.reportPublic FDA data

510(k) K953582

Device
Hfx350, 30kw, 300ma, 1 Or 3 Phase Radiographic & Fluoroscopic X-ray Generator
Applicant
VARIAN CANADA, INC.
510(k) number
K953582
Product code
IZO
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-26
Date received
1995-08-01
Regulation
892.1700
Classification name
Generator, High-Voltage, X-Ray, Diagnostic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT A D'ALVES
Address
45 River Dr. Georgetown, Ontario Canada L7g 2j4 CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IZO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954666MPH50, MPH65, AND MPH80GE Medical Systems1995-11-24
K953831N 800 HFNucletron-Oldelft Corp.1995-09-08
K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.1995-07-12
K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.1995-07-06
K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.1995-04-03
K950694COMPACT-XElectromed Intl., Ltd.1995-03-31
K950291DIGITAL 625HFFischer Imaging Corp.1995-03-23
K950041SII 360 APRScott Imaging Intl., Inc.1995-03-21
K950040SII 525 APRScott Imaging Intl., Inc.1995-03-21
K945453UD 150L-R IIShimadzu Medical Systems1995-03-21
K945452UD 150L-FShimadzu Medical Systems1995-03-21
K950037N 800 HFOldelft Corp. of America1995-02-15
K945731HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORSBennett X-Ray Corp.1995-02-15
K945668KXO-80GToshiba America Medical Systems, In.C1994-12-27
K942731SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GRShimadzu Corp.1994-10-13