510(k) Report

FDA applicant

Siemens Gammasonics, Inc.

Hoffman Estates, IL53 decisions1981–19943 recalls

FDA records 53 decisions for Siemens Gammasonics, Inc. (Hoffman Estates, IL) from 1981 to 1994: 53 510(k) clearances. Most are in product codes IYX (Camera, Scintillation (Gamma)) and KPS (System, Tomography, Computed, Emission). 3 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 Siemens Gammasonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Siemens Gammasonics, Inc. since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Siemens Gammasonics, 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?

  • IYXCamera, Scintillation (Gamma)11decisions
  • KPSSystem, Tomography, Computed, Emission9decisions
  • LLZSystem, Image Processing, Radiological7decisions
  • IZISystem, X-Ray, Angiographic5decisions
  • JWMSystem, Tomographic, Nuclear4decisions
  • IYZBed, Scanning, Nuclear3decisions

Also: IYO (3), LMD (3), LMC (3), ITX (1), JAM (1), KGI (1).

Who builds on its devices?

Later devices cite its devices 12 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.

  • K903315ICONSiemens Gammasonics, Inc. · 19913cite it
  • K914350Icon Computer SystemSiemens Gammasonics, Inc. · 19913cite it
  • K933664Polytron T.O.P. (Time, Operation, Performance)Siemens Gammasonics, Inc. · 19932cite it
  • K920309Sienet Diagnostic Reporting ConsoleSiemens Gammasonics, Inc. · 19921cites it
  • K880690Siemens Pacs/I-aSiemens Gammasonics, Inc. · 19881cites it
  • K920319Sienet Image Display Workstations, Image AcquisitiSiemens Gammasonics, Inc. · 19921cites it

What has FDA decided for it lately?

  • K934766Carbon Fiber PalletSiemens Gammasonics, Inc. · 1994
  • K933664Polytron T.O.P. (Time, Operation, Performance)Siemens Gammasonics, Inc. · 1993
  • K933256Fan Beam CollimatorSiemens Gammasonics, Inc. · 1993
  • K920319Sienet Image Display Workstations, Image AcquisitiSiemens Gammasonics, Inc. · 1992
  • K923582Sienet Camera ServerSiemens Gammasonics, Inc. · 1992
  • K922372Multispect (TM) 3 Triple Detector Camera SystemSiemens Gammasonics, Inc. · 1992
  • K922373Multispect (TM) 2 Dual Detector Camera SystemSiemens Gammasonics, Inc. · 1992
  • K920310Sienet Archive Server, Isa I, Isa II Storage ServeSiemens Gammasonics, Inc. · 19921 recall

All 53 as Siemens Gammasonics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K920310Sienet MagicStore. Radiological Digital Image Communications SystemMay 2, 2007
  • K850397Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical…Feb 10, 2003
  • K903315ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission…Feb 10, 2003