Data / Medical devices / Spain / General Equipment For Medical Imaging, S.A.
General Equipment For Medical Imaging, S.A.: FDA-registered device maker in Valencia Valencia(Province), Spain, 5 510(k) clearances
General Equipment For Medical Imaging, S.A. is registered with the FDA (registration 3008962177) in Valencia Valencia(Province), Spain. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008962177
- Address
- C/Jeronimo de Monsoriu 92 Bajo Izda, Valencia Valencia(Province), Spain, 46022
- Owner or operator
- GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A. (10035514)
- Roles
- Manufacturer
- First device listed
- January 18, 2012
- Registered through
- 2026
- Brand names listed
- GAMMAPRO ANGLED, GAMMAPRO Hi-S, GAMMAPRO LAP, GAMMAPRO STD, GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A., MAMMI BREAST PET, MAMMI DOUBLE RING BREAST PET, MAMMI SINGLE RING BREAST PET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Scintillation (Gamma) | IYX | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 21, 2023 | K232569 | CAREMIBRAIN | KPS | Substantially Equivalent | General Equipment For Medical Imaging, S.A. | accessdata.fda.gov |
| August 18, 2016 | K162052 | Sentinella 102, Sentinella 102 Horus | IYX | Substantially Equivalent | General Equipment For Medical Imaging (Oncovision- | accessdata.fda.gov |
| July 28, 2016 | K161631 | MAMMI | KPS | Substantially Equivalent | General Equipment For Medical Imaging | accessdata.fda.gov |
| November 18, 2014 | K143156 | Sentinella 102; Sentinella 102 Horus | IYX | Substantially Equivalent | General Equipment For Medical Imaging (Oncovision- | accessdata.fda.gov |
| June 11, 2014 | K140996 | MAMMI | KPS | Substantially Equivalent | General Equipment For Medical Imaging (Oncovision- | accessdata.fda.gov |
Compare with other makers
- All makers of System, Tomography, Computed, Emission
- All makers of Camera, Scintillation (Gamma)
- All makers of Probe, Uptake, Nuclear
Updated September 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.