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510(k) K914179

CARDIOFOCAL COLLIMATOR by Siemens Gammasonics, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
September 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Siemens Gammasonics, Inc.

  • K934766 — CARBON FIBER PALLET (February 18, 1994)
  • K933664 — POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) (December 15, 1993)
  • K933256 — FAN BEAM COLLIMATOR (October 29, 1993)
  • K920319 — SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI (October 20, 1992)
  • K923582 — SIENET CAMERA SERVER (October 14, 1992)
  • K922373 — MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM (August 17, 1992)
  • K922372 — MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM (August 17, 1992)
  • 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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