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JWM — System, Tomographic, Nuclear Class II

FDA Device Classification

Classification Details

Product Code
JWM
Device Class
Class II
Regulation Number
892.1310
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914350siemens gammasonicsICON COMPUTER SYSTEMNovember 22, 1991
K904599digital designD2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMApril 23, 1991
K903315siemens gammasonicsICONJanuary 9, 1991
K901545toshiba america medical systems, in.cGCA-9300 NUCLEAR TOMOGRAPHY SYSTEMJune 26, 1990
K874473adac laboratoriesADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMJuly 18, 1988
K873075adac laboratoriesADAC MODEL ARC-5000, GAMMA CAMERAOctober 30, 1987
K851685toshiba medical systemsDIGITAL GAMMA CAMERA GCA 601 EJune 14, 1985
K850885general electricSTARCAM DATA ACQUISITION & PROCESSING SYS H3300CJune 6, 1985
K851686toshiba medical systemsDIGITAL GAMMA CAMERA GCA 501SJune 5, 1985
K851687toshiba medical systemsJUMBO DIGITAL GAMMACAMERA GCA-90BJune 5, 1985
K841905siemens gammasonicsDOT-A, DOT-AR PXP-E, PXP-ERAugust 9, 1984
K832737siemens gammasonicsECT PROCESSORSeptember 29, 1983
K812966general electric400T ECT SOFTWARENovember 24, 1981
K810873intl. general electricSTARApril 23, 1981
K801917general electricSTARSeptember 16, 1980
K780368medtronic vascularMODUMED MUGXMarch 14, 1978
K780369medtronic vascularMODUMED MUGEMarch 14, 1978