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510(k) K772125

TOMOGRAPHIC SCANNER, COMPUTERIZED by Emi Medical, Inc. — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1977
Date Received
November 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
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)
  • K780736 — CT 5221 DOSE REDUCING COLLIMATORS (June 2, 1978)
  • K780737 — CT BLANKETS (BOLUS MATERIAL) (June 2, 1978)
  • K771978 — CTR 100L (November 23, 1977)

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