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510(k) K905074

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM by Siemens Gammasonics, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1991
Date Received
November 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
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)
  • K914313 — HICOR (November 27, 1991)

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