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510(k) K894931

SOPHYCAMERA DSX RECTANGULAR by Sopha Medical Systems, Inc. — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1989
Date Received
August 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

Other clearances by Sopha Medical Systems, Inc.

  • K952190 — TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE (January 18, 1996)
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  • K921008 — VECTOR SERIES (April 27, 1992)
  • K913641 — SOPHY NXT (December 17, 1991)
  • K911346 — SOPHYCAMERA DSX BODYTRAK (April 18, 1991)
  • 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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