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510(k) K912286

CARDIAC SPECT PALLET by Siemens Gammasonics, Inc. — Product Code IYZ

K912286 is an FDA 510(k) premarket notification submitted by Siemens Gammasonics, Inc. for the device "CARDIAC SPECT PALLET". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code IYZ (Bed, Scanning, Nuclear), a Class I device regulated under 21 CFR 892.1350. Siemens Gammasonics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
May 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Scanning, Nuclear
Device Class
Class I
Regulation Number
892.1350
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)

Other clearances for product code IYZ

  • K920962 — MULTIPLE ACCESSORY TO GAMMA CAMERAS (April 17, 1992)
  • K915541 — SPECT TABLE, MODEL #056-760 (January 17, 1992)
  • K911691 — XYZ CRANK IMAGING TABLE (August 9, 1991)
  • K912481 — ECT CARBON FIBER PALLET, MODIFICATION (August 2, 1991)
  • K912181 — E-Z LIFT CRANK IMAGING TABLE (July 17, 1991)
  • K912135 — XY IMAGING TABLE (July 17, 1991)
  • K911561 — XYZ IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K911564 — E-Z LIFT IMAGING TABLE WITH FOOT PUMP (July 15, 1991)
  • K903901 — SCANNING COT (September 21, 1990)
  • K903767 — ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL (September 7, 1990)

FDA data resources