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510(k) K780736

CT 5221 DOSE REDUCING COLLIMATORS by Emi Medical, Inc. — Product Code IZX

K780736 is an FDA 510(k) premarket notification submitted by Emi Medical, Inc. for the device "CT 5221 DOSE REDUCING COLLIMATORS". The FDA issued a decision of Substantially Equivalent on June 2, 1978. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Emi Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1978
Date Received
May 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances by Emi Medical, Inc.

  • K791429 — EMISONIC 4290 (September 21, 1979)
  • K781936 — SCANNER-EMI 7020 AND 7020R (December 4, 1978)
  • K781519 — EMI SIMULATOR REMOTE CONTROL CONSOLE (September 14, 1978)
  • K781051 — EMISONIC 4201 (July 17, 1978)
  • K780995 — COMPUTERIZED AXIAL TOMOGRAPHY (June 22, 1978)
  • K780930 — 5543 INDEPENDENT VIEWING SYSTEM (June 14, 1978)
  • K780928 — CT5137 HIGH RESOLUTION OPTION (June 14, 1978)
  • K780737 — CT BLANKETS (BOLUS MATERIAL) (June 2, 1978)
  • K771978 — CTR 100L (November 23, 1977)
  • K772125 — TOMOGRAPHIC SCANNER, COMPUTERIZED (November 21, 1977)

Other clearances for product code IZX

  • K110856 — RALCO (August 10, 2011)
  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 2010)
  • K042840 — SHIMADZU COLLIMATOR R-20J (December 3, 2004)
  • K031771 — SHIMADZU COLLIMATOR R-30H (August 21, 2003)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (October 21, 1991)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)

FDA data resources