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510(k) K914350

ICON COMPUTER SYSTEM by Siemens Gammasonics, Inc. — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1991
Date Received
September 27, 1991
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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  • K923582 — SIENET CAMERA SERVER (October 14, 1992)
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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)
  • K914313 — HICOR (November 27, 1991)

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  • 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)