Data / Medical devices / Netherlands / Benelux Imaging
Benelux Imaging: FDA-registered device maker in Hilversum Noord-Holland, Netherlands, 11 510(k) clearances and 1 PMA approval
Benelux Imaging is registered with the FDA (registration 3029521953) in Hilversum Noord-Holland, Netherlands. It lists 6 device types. The FDA files 11 510(k) clearances and 1 PMA approval under its listings, the newest dated August 27, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029521953
- Address
- Burgemeester Gulcherlaan 24, Hilversum Noord-Holland, Netherlands, 1217PC
- Owner or operator
- Benelux Imaging (10088672)
- Roles
- Exporter to the US
- First device listed
- October 3, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US | accessdata.fda.gov |
| Digital Breast Tomosynthesis | OTE | 3 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Spectroscopic | LNI | 2 | Exporter to the US | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 27, 2021 | K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 4, 2020 | K202238 | SIGNA Artist | LNH | Substantially Equivalent | Ge Healthcare (Tianjin) Company Limited | accessdata.fda.gov |
| February 15, 2019 | K190138 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 1, 2016 | K161567 | SIGNA Voyager | LNH | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 9, 2016 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 24, 2015 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 29, 2015 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 3, 2011 | K111445 | DISCOVERY NM 630 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Digital Breast Tomosynthesis
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Tomography, Computed, Emission
- All makers of System, X-Ray, Tomography, Computed
Updated November 24, 2025. 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.