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510(k) K911346

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

K911346 is an FDA 510(k) premarket notification submitted by Sopha Medical Systems, Inc. for the device "SOPHYCAMERA DSX BODYTRAK". The FDA issued a decision of Substantially Equivalent on April 18, 1991. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. Sopha Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
March 27, 1991
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)
  • K942837 — DST-XL (January 5, 1995)
  • K921008 — VECTOR SERIES (April 27, 1992)
  • K913641 — SOPHY NXT (December 17, 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)

Other clearances for product code IYX

  • K230221 — QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiot (August 28, 2023)
  • K212587 — 3D-RD-S (February 22, 2023)
  • K163687 — OLINDA EXM (July 19, 2017)
  • K160933 — Discovery NM 750b Bopsy (November 18, 2016)
  • K162052 — Sentinella 102, Sentinella 102 Horus (August 18, 2016)
  • K143156 — Sentinella 102; Sentinella 102 Horus (November 18, 2014)
  • K123408 — ERGO IMAGING SYSTEM (January 15, 2013)
  • K111791 — LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (September 23, 2011)
  • K110384 — DILON 6800 ACELLA (ACELLA) (May 3, 2011)
  • K110601 — SENTINELLA 102 (March 18, 2011)

FDA data resources