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510(k) K842895

Device
WBA - I.R.I.S.
Applicant
SIEMENS GAMMASONICS, INC.
510(k) number
K842895
Product code
JAM  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-27
Date received
1984-07-23
Regulation
892.1330
Classification name
Scanner, Whole Body, 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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K841996MAXICAMERA 400T W/BODY CONTOUR TOMOGRAGeneral Electric Co.1984-07-16
K770530CLEON IMAGERUnion Carbide Corp.1977-04-05

Legacy Summary#

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FDA Review#

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