Data / Medical devices / Denmark / Scandinavian Medical Solutions A/S
Scandinavian Medical Solutions A/S: FDA-registered device maker in Aalborg Nordjylland, Denmark, 34 510(k) clearances
Scandinavian Medical Solutions A/S is registered with the FDA (registration 3017375271) in Aalborg Nordjylland, Denmark. It lists 11 device types. The FDA files 34 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017375271
- Address
- Gasvaerksvej 48 1st Floor, Aalborg Nordjylland, Denmark, 9000
- Owner or operator
- Scandinavian Medical Solutions A/S (10077435)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 27, 2020
- Registered through
- 2027
- Brand names listed
- Biograph mCT 20 Flow, GE Discovery IQ5R, GE MR 450W, GE Optima CT660, GE Revolution CT Apec Edition 512, GE Revolution EVO 128, GE Voyager 1.5T, Optima MR430S 1, 5T and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Exporter to the US | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Exporter to the US | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Exporter to the US, Manufacturer | 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, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | LNH | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| July 9, 2025 | K251520 | Cios Alpha; Cios Flow | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 14, 2023 | K232494 | MAGNETOM Avanto fit; MAGNETOM Skyra fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 23, 2023 | K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 13, 2022 | K220589 | MAGNETOM Skyra Fit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 17, 2021 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 8, 2020 | K202014 | Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit | LNH | 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 14, 2020 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 12, 2020 | K193178 | Biograph Horizon | KPS | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| September 6, 2018 | K182234 | Optima XR240amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 25, 2016 | K161973 | G-scan Brio, S-scan | LNH | Substantially Equivalent | Esaote, S.p.A. | 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 |
| July 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 16, 2015 | K143416 | SOMATOM Definition Flash (VA48) | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141477 | DISCOVERY IQ | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 11, 2014 | K133705 | REVOLUTION CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 24, 2013 | K131773 | BRILLIANCE ICT | JAK | Substantially Equivalent | Philips Healthcare (Cleveland) | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 22, 2013 | K122286 | MAMMOMAL INSPIRATION | MUE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 29, 2013 | K123873 | CONTRAST ENHANCED DIGITAL MAMMOGRAPHY | MUE | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| December 17, 2011 | K113448 | BIOGRAPH MCT FAMILY | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 6, 2011 | K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL | MUE | Substantially Equivalent | General Electric Company | accessdata.fda.gov |
| April 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 24, 2009 | K091673 | GE LIGHTSPEED ACT FP16 | JAK | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
| September 25, 2008 | K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | MOS | Substantially Equivalent | Quality Electrodynamics | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 10, 2007 | K072237 | MAGNETOM VERIO | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 21, 2004 | K041112 | MAGNETOM ESPREE SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated December 19, 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.