FDA Device Registration & Listing · Aalborg Nordjylland, DK · Registration 3009196578
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-05 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-05 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-05 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2026-03-31 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-01-24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-01-24 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-01-24 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-04 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-04 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2020-06-09 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2020-06-09 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2020-06-09 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-07-23 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-07-23 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-07-23 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2024-07-23 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-10-03 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-10-03 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-10-03 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-09-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-09-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-09-22 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2026-06-03 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-16 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-16 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-16 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2018-01-16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-03-27 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-03-27 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-03-27 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2026-03-27 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2018-03-07 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-03-07 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-03-07 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-03-07 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-04-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-04-22 |
| QIH | Automated Radiological Image Processing Software | Radiology | Class 2 | 892.2050 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-24 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-24 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-02-05 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2021-02-05 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-02-05 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-02-05 |
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | Class 2 | 872.1800 | 2024-12-11 |
| OAS | X-Ray, Tomography, Computed, Dental | Radiology | Class 2 | 892.1750 | 2024-12-11 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-12-21 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-12-21 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-12-21 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-09-27 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-09-27 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-09-27 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Radiology | Class 2 | 892.1715 | 2024-03-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-04-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-04-22 |
| QIH | Automated Radiological Image Processing Software | Radiology | Class 2 | 892.2050 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-04-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-02-08 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-02-08 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-02-08 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-12-04 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2018-12-04 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-12-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-12-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-12-18 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-12-18 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-12-18 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-05 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-05 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-05 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-05-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-05-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-05-22 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2026-03-03 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2026-03-03 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2022-07-14 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-02-28 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2025-02-28 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-02-28 |
| QIH | Automated Radiological Image Processing Software | Radiology | Class 2 | 892.2050 | 2025-02-28 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-02-28 |
| KPS | System, Tomography, Computed, Emission | Radiology | Class 2 | 892.1200 | 2024-05-07 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2024-05-07 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2023-02-23 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2023-02-23 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2023-02-23 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2026-03-31 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2024-06-26 |
| QIH | Automated Radiological Image Processing Software | Radiology | Class 2 | 892.2050 | 2025-04-30 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2025-04-30 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-04-30 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-04-30 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-04-30 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-03-21 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-03-21 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-03-21 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-01-14 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-01-14 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-01-14 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-02 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-02 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-03-03 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-03-03 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-03-03 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-02-12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-02-12 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-02-12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-01-06 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-01-06 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-01-06 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-05-18 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-05-18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-05-18 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-12-18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-12-18 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-12-18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-02-12 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-02-12 |
| KPS | System, Tomography, Computed, Emission | Radiology | Class 2 | 892.1200 | 2025-07-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-24 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-24 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-02-12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-02-12 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-02-12 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2025-07-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-10-25 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-10-25 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-10-25 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2022-10-25 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2022-10-25 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2022-10-25 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-10-03 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-10-03 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-10-03 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2017-10-03 |
| KPS | System, Tomography, Computed, Emission | Radiology | Class 2 | 892.1200 | 2025-07-25 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-02 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-02 |
| IZH | System, X-Ray, Mammographic | Radiology | Class 2 | 892.1710 | 2024-02-20 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-12-04 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-12-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-12-04 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-07-14 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-07-14 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-07-14 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2023-03-13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2023-03-13 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2023-03-13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-04-01 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-04-01 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-04-01 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-05-18 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-05-18 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-05-18 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-08-29 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-08-29 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-08-29 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-04-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-04-22 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-04-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-04-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-03-18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-03-18 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-03-18 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2025-07-30 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-07-30 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-07-30 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-07-30 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-07-26 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-07-26 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2018-07-26 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-07-26 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-04-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-04-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-10-03 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2017-10-03 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-10-03 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-10-03 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2021-04-28 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2021-04-28 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2021-04-28 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-09-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-09-04 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-09-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-08-14 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-08-14 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-08-14 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-04 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-04 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-04 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2026-03-31 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | Class 2 | 892.1650 | 2026-03-31 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | Class 2 | 892.1650 | 2022-01-03 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | Class 2 | 892.1650 | 2022-01-03 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | Class 2 | 892.1650 | 2022-01-03 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2026-05-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2026-05-04 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2026-05-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-10-26 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-10-26 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-10-26 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-02 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-02 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-02 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2026-03-05 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | Radiology | Class 2 | 892.1715 | 2026-03-24 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-11-14 |
| OIJ | Biopsy Needle Guide Kit | Radiology | Class 2 | 892.1560 | 2024-11-14 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-11-14 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-11-14 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2017-11-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2017-11-22 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2017-11-22 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2025-04-16 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-04-16 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2025-04-16 |
| OTE | Digital Breast Tomosynthesis | Unknown | Class 3 | N/A | 2026-02-10 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2022-06-17 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-06-17 |
| QIH | Automated Radiological Image Processing Software | Radiology | Class 2 | 892.2050 | 2022-06-17 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2022-06-17 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-02-12 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-02-12 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-02-12 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | Class 2 | 892.1650 | 2025-07-30 |
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | Class 2 | 892.1650 | 2025-07-30 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | Radiology | Class 2 | 892.1650 | 2025-07-30 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-05-10 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2019-05-10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2019-05-10 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-01-05 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-01-05 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-01-05 |
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | Class 2 | 870.1200 | 2018-01-05 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2018-12-04 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2018-12-04 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2018-12-04 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | Class 2 | 892.1000 | 2026-03-31 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K882805 | Coopervision-Cilco | CILCO VILLASENOR PACHYMETER | 1988-08-12 |
| K791040 | Shimadzu Corp. | SECTOR SCANNER, SDU-100, COMPUTERIZED | 1979-10-04 |
| K162372 | Qt Ultrasound, LLC | QT Ultrasound Breast Scanner-1 | 2017-06-06 |
| K930964 | Acuson Corp. | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) | 1994-10-26 |
| K052355 | U-Systems, Inc. | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | 2005-09-14 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-2011 | Verathon, Inc. | 2 | BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements. |
| Z-0004-2011 | Verathon, Inc. | 2 | AortaScan AMI 9700
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements |
| Z-0005-2011 | Verathon, Inc. | 2 | BladderScan BVM 9500
The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively. |
| Z-0027-2014 | SonoSite, Inc. | 2 | P21x/5-1 MHz transducer, Part Number P07698-23
Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler. |
| Z-0189-2022 | FujiFilm Healthcare Americas Corporation | 2 | Arietta 750 Ultrasound
Software Version: V1.0.0 through V2.1.3 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3008515880 | EZONO AG | Jena Thuringia, DE |
| 3029744051 | LYSIS HEALTHCARE GMBH | Graz Steiermark, AT |
| 3014574557 | ADECHOTECH | NAVEIL Loir-et-Cher, FR |
| 3012081348 | THE SENTINEL IMAGING GROUP, INC | Clarks Summit, PA, US |
| 3025786376 | ACO HEALTHCARE CO., LTD. | Taoyuan City, TW |
3009196578 when referencing this establishment in official correspondence.