Data / Medical devices / Denmark / Agito Medical
Agito Medical: FDA-registered device maker in Norresundby Nordjylland, Denmark, 28 510(k) clearances
Agito Medical is registered with the FDA (registration 3007562060) in Norresundby Nordjylland, Denmark. It lists 10 device types. The FDA files 28 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007562060
- Address
- Bejlerholm 3a, Norresundby Nordjylland, Denmark, 9400
- Owner or operator
- AGITO Medical A/S (10091434)
- Roles
- Exporter to the US
- First device listed
- October 4, 2024
- Registered through
- 2026
- Brand names listed
- OPTITOP 150/30/50HC-100
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Exporter to the US | accessdata.fda.gov |
| Biopsy Needle Guide Kit | OIJ | 2 | Exporter to the US | accessdata.fda.gov |
| Coil, Magnetic Resonance, Specialty | MOS | 2 | Exporter to the US | accessdata.fda.gov |
| Collimator, Automatic, Radiographic | IZW | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | 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, X-Ray, Tomography, Computed | JAK | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
| August 16, 2022 | K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | IYN | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | 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 |
| June 27, 2019 | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 9, 2018 | K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182129 | MAGNETOM Sola | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 27, 2018 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| February 13, 2018 | K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172695 | AIR Anterior Array, AIR Posterior Array | MOS | Substantially Equivalent | Ge Healthcare Coils (Usa Instruments, Inc.) | accessdata.fda.gov |
| October 4, 2017 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Health Care | 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 |
| January 27, 2017 | K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2016 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| April 6, 2016 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
| November 18, 2015 | K152758 | Venue 50 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 30, 2015 | K152899 | Philips Lumify Diagnostic Ultrasound System | IYN | Substantially Equivalent | Philips Healthcare, Inc. | accessdata.fda.gov |
| April 8, 2015 | K143400 | SOMATOM Definition AS/AS+ | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 15, 2014 | K140912 | SOMATOM SCOPE/SOMATOM SCOPE POWER | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 24, 2013 | K133431 | VENUE 50 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 6, 2013 | K130645 | AQUILION PRIME, V5.00 | JAK | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| November 5, 2012 | K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | LNH | Substantially Equivalent | Siemens Medi Cal Solutions, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113474 | 1.5T GEM FLEX COIL | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| September 23, 2011 | K112122 | VENUE 40 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 11, 2011 | K103275 | SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 23, 2010 | K103342 | 3.0T METAFLEXCOIL | MOS | Substantially Equivalent | Neocoil, LLC | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 24, 2008 | K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | Philips Ultrasound, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Nuclear Magnetic Resonance Spectroscopic
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Coil, Magnetic Resonance, Specialty
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
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.