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510(k) K840131

Device
COMPUTED TOMOGRAPHY CALIBRATION PHANT
Applicant
IMATRON, INC.
510(k) number
K840131
Product code
IXG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-02-21
Date received
1984-01-10
Regulation
892.1950
Classification name
Phantom, Anthropomorphic, Radiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IXG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913243BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLEBennett X-Ray Corp.1991-09-19
K852528BONE DENSITY CT PHANTOMComputerized Imaging Reference Systems, Inc.1985-09-26
K834465SERIES OF DIAGNOSTIC PHANTOMSCirs, Inc.1984-02-21

Legacy Summary#

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FDA Review#

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