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510(k) K901545

GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM by Toshiba America Medical Systems, In.C — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1990
Date Received
April 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
Review Panel
RA
Submission Type

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  • K851686 — DIGITAL GAMMA CAMERA GCA 501S (June 5, 1985)
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  • K841905 — DOT-A, DOT-AR PXP-E, PXP-ER (August 9, 1984)