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510(k) K780395

Device
IMAGER, BODY SECTION, RADIONUCLIDE
Applicant
UNION CARBIDE CORP.
510(k) number
K780395
Product code
IYW  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-31
Date received
1978-03-13
Regulation
892.1300
Classification name
Scanner, Rectilinear, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944684POLYSCAN DIGITAL SCANNERMse Medizintechnik GmbH & Co. KG1995-05-15
K895799RECTILINEAR SCANNER MODEL #187-270Atomic Products Corp.1990-02-01
K882453POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.1988-11-23

Legacy Summary#

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FDA Review#

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