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510(k) K913641

SOPHY NXT by Sopha Medical Systems, Inc. — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
August 13, 1991
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.

  • K952190 — TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE (January 18, 1996)
  • K942837 — DST-XL (January 5, 1995)
  • K921008 — VECTOR SERIES (April 27, 1992)
  • 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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