LBN MEDICAL A/S

FDA Device Registration & Listing · Aalborg Nordjylland, DK · Registration 3009196578

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009196578
FEI Number
3009196578
Entity Name
LBN MEDICAL A/S
City/State/Country
Aalborg Nordjylland, DK
Establishment Address
Gugvej 70, Aalborg Nordjylland 9210, DK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
LBN Medical ApS (Owner Number: 10055731)
Owner / Operator Contact Address
Gugvej 70, Aalborg, DK-81 9210, DK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Sonosite Probe L38 Sonosite Probe HFL 38 GE Brightspeed 16 GE Probe 4VC-D GE Probe RAB6-RS SAMSUNG V5-9 Siemens 10EV3 Philips probe C8-5 for Epiq Philips Probe C9-2 for Epiq GE L2-9D GE Logiq E10 GE C2-9D GE Optima MR450W Siemens probe 6C1 HD for S2000 Acuson Probe V5M Siemens Acuson Redwood Acuson Probe EV8C4 GE RIC5-9-H probe GE RAB4-8L probe GE Probe 3S GE Probe 4C-RS convex Siemens 18L6 HD XW8000 Workstation PHILIPS S5-1 GE TE 100024 probe GE Logiq S8 GE Probe P2D CW Doppler GE probe S1-5 GE Probe L3-12-D Hologic Selenia Dimensions 8000 Hologic Selenia Dimensions TOMO GE C2-7D probe Toshiba Probe PLT-1204BT Toshiba Probe PVT-375BT Toshiba Probe PVT-661VT Toshiba Probe PST-25BT Sonosite M-Turbo Portable Philips Probe C6-2 for Affinit PHILIPS EL18-4 Sonosite MicroMaxx Samsung V8 Ulstrasound L8-3 freesyle GE Optima CT580 Siemens 12L3 Siemens MC9-4 Siemens 10L4 GE Revolution EVO Esaote G-scan Brio 0.25T Philips Epiq CVx ultrasound GE Probe RIC5-9D BK Medical 8823 BK Medical Flex Focus 400 BK Medical 8809 BK Medical 8870 Philips Probe C10-4EC Philips Probe 3D9-3V for Epiq Philips Probe VL13-5 GE L8-18I-SC GE 10C-SC GE RAB6-D GE S6S-RS transducer GE E8C-RS transducer GE M5SC-RS Canon Aplio i800 GE Probe RIC5-9H 4D vaginal GE Discovery 710 Toshiba Probe PLT-805AT GE probe L8-18i-D intraoper GE Probe 4V-D 4D sector Canon Aquilion One Siemens 5C1 Siemens 18L6 Siemens 9EC4 Siemens 10L4 Siemens 12L4 Siemens 14L5 Acuson Probe 9L4 S2000/SC2000 Philips Brightview XCT Hitachi Probe C715 for Preirus Hologic Selenia Dimensions 3D GE 6VT-D probe Vivid E9 Sonosite Convex probe C60 GE C1-5-RS GE RIC6-12D GE Vivid S70 GE Vivid IQ GE HDXT Signa 1,5T Terason 15L4 Siemens Magnetom Aera 1.5T Samsung CA2-9AD probe Samsung LA4-18B probe Philips Probe C8-5 microconvex Siemens Acuson Redwood Acuson Probe EC9-4 vaginal Acuson TEE Probe V7M GE RIC5-9W-RS probe GE E8C-RS probe Acuson Probe 9L4 S2000/SC2000 GE ML6-15-D GE L8-18I-D GE Probe M4S-RS Hitachi L441 ultrasound transducer Toshiba Probe PLT-1204BX GE LightSpeed 16 Canon Vantage Elan 1.5T GE OEC 9900 Elite D2CWC GE Vivid I Portable GE Probe 12L-RS GE Probe 8C GE Probe 8C-rs Aquilion Prime Hologic Selenia Dimensions 3000 2D Hologic Selenia Dimensions TOMO 3D Hologic Selenia Dimensions 8000 TOMO Siemens 5C1 Philips D2cwc Philips Probe 3D9-3V for IU22 Philips probe L17-5 for IU22 PHILIPS X5-1 GE 3SP-D Hologic 3Dimensions Hologic Selenia Dimensions 5000 3D Hologic Selenia Dimensions TOMO 3D Hologic Selenia Dimensions 5000 Hologic Selenia Dimensions 8000 3D Hologic Selenia Dimensions 8000 TOMO Philips CX50 GE Probe 4C-SC 1.8-5 MHz Ziehm Vision RFD GE Probe RIC5-9A-RS Acuson probe 4V1C Siemens 4V1C GE Probe RAB4-8-RS4D abdominal GE Optima MR450W

Registered Product Listings

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

Official Correspondent

Jesper Nielsen

US Agent Details

Quinn Leach Business: DirectMed Imaging Email: qleach@DirectMedImaging.com Phone: (858) 3776143

Related Public Records

Same Entity

LBN Medical ApS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

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

Related Recall Records

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

Similar Registrations

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
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009196578. Last updated year: 2026. Please use registration number 3009196578 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
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