510(k) Report

FDA applicant

Sopha Medical Systems, Inc.

Columbia, MD8 decisions1987–19964 recalls

FDA records 8 decisions for Sopha Medical Systems, Inc. (Columbia, MD) from 1987 to 1996: 8 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sopha Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sopha Medical Systems, Inc. since 2007.

Recalls per year

2in 2025

2008: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sopha Medical Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission4decisions
  • IYXCamera, Scintillation (Gamma)3decisions
  • IXYHolder, Radiographic Cassette, Wall-Mounted1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K952190Transmission Attenuation Correction (Tac) PackageSopha Medical Systems, Inc. · 19961cites it
  • K913641Sophy NXTSopha Medical Systems, Inc. · 19911cites it

What has FDA decided for it lately?

  • K952190Transmission Attenuation Correction (Tac) PackageSopha Medical Systems, Inc. · 1996
  • K942837DST-XLSopha Medical Systems, Inc. · 19952 recalls
  • K921008Vector SeriesSopha Medical Systems, Inc. · 1992
  • K913641Sophy NXTSopha Medical Systems, Inc. · 1991
  • K911346Sophycamera DSX BodytrakSopha Medical Systems, Inc. · 19911 recall
  • K894931Sophycamera DSX RectangularSopha Medical Systems, Inc. · 19891 recall
  • K872132Sophy Series of Nuclear Medicine Computer SystemsSopha Medical Systems, Inc. · 1987
  • K872297DS-7 Nuclear Medicine Gamma CameraSopha Medical Systems, Inc. · 1987

All 8 as Sopha Medical Systems, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K894931SMV DSX New Line, System, Tomography, Computed, EmissionDec 10, 2025Class II
  • K911346SMV BodyTrack, System, Tomography, Computed, EmissionDec 10, 2025Class II
  • K942837DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body…Mar 10, 2008
  • K942837Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging SystemSep 27, 2005