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510(k) K882453

Device
POLYSCAN DIGITAL SCANNER
Applicant
MEDICAL AND SCIENTIFIC ENTERPRISES, INC.
510(k) number
K882453
Product code
IYW  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-23
Date received
1988-06-14
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#

Contact
EDUARD J BOTZ
Address
56 Union Ave. P.O. Box 806 Sudbury MA US 01776 01776

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
K780395IMAGER, BODY SECTION, RADIONUCLIDEUnion Carbide Corp.1978-03-31

Legacy Summary#

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FDA Review#

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