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510(k) K903315

ICON by Siemens Gammasonics, Inc. — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1991
Date Received
July 24, 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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  • K920310 — SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE (March 30, 1992)
  • K920309 — SIENET DIAGNOSTIC REPORTING CONSOLE (March 20, 1992)
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Other clearances for product code JWM

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  • K901545 — GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM (June 26, 1990)
  • K874473 — ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM (July 18, 1988)
  • K873075 — ADAC MODEL ARC-5000, GAMMA CAMERA (October 30, 1987)
  • K851685 — DIGITAL GAMMA CAMERA GCA 601 E (June 14, 1985)
  • K850885 — STARCAM DATA ACQUISITION & PROCESSING SYS H3300C (June 6, 1985)
  • K851686 — DIGITAL GAMMA CAMERA GCA 501S (June 5, 1985)
  • K851687 — JUMBO DIGITAL GAMMACAMERA GCA-90B (June 5, 1985)
  • K841905 — DOT-A, DOT-AR PXP-E, PXP-ER (August 9, 1984)