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510(k) K952190

TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE by Sopha Medical Systems, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1996
Date Received
May 9, 1995
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 Sopha Medical Systems, Inc.

  • K942837 — DST-XL (January 5, 1995)
  • K921008 — VECTOR SERIES (April 27, 1992)
  • K913641 — SOPHY NXT (December 17, 1991)
  • K911346 — SOPHYCAMERA DSX BODYTRAK (April 18, 1991)
  • K894931 — SOPHYCAMERA DSX RECTANGULAR (October 27, 1989)
  • K872132 — SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS (October 26, 1987)
  • K872297 — DS-7 NUCLEAR MEDICINE GAMMA CAMERA (August 12, 1987)

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