Camera, Scintillation (Gamma)
Regulation 892.1100
0510(k)s in 12 months (130 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in IYX
| Company | 510(k)s | Recalls |
|---|---|---|
| General Electric Co. | 15 | 0 |
| Siemens Gammasonics, Inc. | 11 | 0 |
| Adac Laboratories | 6 | 0 |
| Elscint, Inc. | 5 | 0 |
| Medtronic Vascular | 5 | 0 |
| Toshiba Medical Systems | 5 | 0 |
| Medx, Inc. | 4 | 0 |
| Union Carbide Corp. | 4 | 0 |
| Digirad Corp. | 3 | 0 |
| Dilon Technologies, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV BodyTrack,
System, Tomography, Computed, Emission Open, Classified |
IYX | K911346 |
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV DSX New Line,
System, Tomography, Computed, Emission Open, Classified |
IYX | K894931 |
| Aug 5, 2016 | Siemens Medical Solutions USA, Inc. e.cam and Symbia E gamma camera systems with patient beds
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging Terminated |
IYX | K142006 |
| Aug 24, 2004 | General Electric Med Systems SMV FX-80 Nuclear Camera Terminated |
IYX | K935273 |
| Aug 24, 2004 | General Electric Med Systems SMV FX-40 Nuclear Camera Terminated |
IYX | K935273 |
| Feb 10, 2004 | GVI Technology Partners CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech. Terminated |
IYX | K023373 |
| Mar 6, 2003 | Siemens Medical Solutions USA, Inc. Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203 Terminated |
IYX | K850397 |
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