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510(k) K780995

COMPUTERIZED AXIAL TOMOGRAPHY by Emi Medical, Inc. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
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)
  • K780930 — 5543 INDEPENDENT VIEWING SYSTEM (June 14, 1978)
  • K780928 — CT5137 HIGH RESOLUTION OPTION (June 14, 1978)
  • K780737 — CT BLANKETS (BOLUS MATERIAL) (June 2, 1978)
  • K780736 — CT 5221 DOSE REDUCING COLLIMATORS (June 2, 1978)
  • K771978 — CTR 100L (November 23, 1977)
  • K772125 — TOMOGRAPHIC SCANNER, COMPUTERIZED (November 21, 1977)

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