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510(k) K832737

Device
ECT PROCESSOR
Applicant
SIEMENS GAMMASONICS, INC.
510(k) number
K832737
Product code
JWM  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-29
Date received
1983-08-11
Regulation
892.1310
Classification name
System, Tomographic, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JWM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.1991-11-22
K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.1991-04-23
K903315ICONSiemens Gammasonics, Inc.1991-01-09
K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.C1990-06-26
K874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac Laboratories1988-07-18
K873075ADAC MODEL ARC-5000, GAMMA CAMERAAdac Laboratories1987-10-30
K851685DIGITAL GAMMA CAMERA GCA 601 EToshiba Medical Systems1985-06-14
K850885STARCAM DATA ACQUISITION & PROCESSING SYS H3300CGeneral Electric Co.1985-06-06
K851686DIGITAL GAMMA CAMERA GCA 501SToshiba Medical Systems1985-06-05
K851687JUMBO DIGITAL GAMMACAMERA GCA-90BToshiba Medical Systems1985-06-05
K841905DOT-A, DOT-AR PXP-E, PXP-ERSiemens Gammasonics, Inc.1984-08-09
K812966400T ECT SOFTWAREGeneral Electric Co.1981-11-24
K810873STARIntl. General Electric Co.1981-04-23
K801917STARGeneral Electric Co.1980-09-16
K780368MODUMED MUGXMedtronic Vascular1978-03-14

Legacy Summary#

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FDA Review#

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