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510(k) K944684

Device
POLYSCAN DIGITAL SCANNER
Applicant
MSE MEDIZINTECHNIK GMBH & CO. KG
510(k) number
K944684
Product code
IYW  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-15
Date received
1994-09-22
Regulation
892.1300
Classification name
Scanner, Rectilinear, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
EDUARD J BOTZ
Address
Carl Zeiss Strasses 18, D-6074 Rodemark DE D-6074 D-6074

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
K895799RECTILINEAR SCANNER MODEL #187-270Atomic Products Corp.1990-02-01
K882453POLYSCAN DIGITAL SCANNERMedical and Scientific Enterprises, Inc.1988-11-23
K780395IMAGER, BODY SECTION, RADIONUCLIDEUnion Carbide Corp.1978-03-31

Legacy Summary#

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FDA Review#

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