BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GE Healthcare Japan Corporation

    Reg #: 9612283 · FEI: 3002808529 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    307
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    GE Healthcare Japan Corporation
    Registration Number
    9612283
    FEI Number
    3002808529
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7-127, Asahigaoka 4-chome
    City
    HINO-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K253370

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, X-Ray, Tomography, Computed JAK
    Catheter, Ultrasound, Intravascular OBJ
    Table, Radiographic, Non-Tilting, Powered IZZ
    Device, Percutaneous, Biopsy MJG

    Proprietary Names

    6S-D LOGIQ Totus C1-6VN-D ML6-15-D L6-24-D C1-6-D P2D L4-20t-D M5Sc-D C2-9-D 6Tc-RS P6D IC5-9-D RAB6-D L3-12-D C3-10-D RIC5-9-D RAB2-6-RS L6-12-RS C1-5-RS LOGIQ P9 8C-RS M5sc-RS 9L-RS ML6-15-RS L8-18i-RS L3-12-RS 3Sc-RS L4-12t-RS L10-22-RS 12L-RS LOGIQ P10 E8CS-RS 6S-RS BE9CS-RS LOGIQ P8 E8C-RS IC9-RS 12S-RS RIC5-9A-RS E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG RAB4-8-RS Voluson i Voluson e RAB2-5-RS 4C-RS RIC5-9W-RS RNA5-9-RS True Enhance DL Venue Go M5Sc-RS C2-9-RS L4-20t-RS E8Cs-RS Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG Vivid T9 Vivid T8 9T-RS LK760-RS LOGIQ V2 LOGIQ V1 Venue Fit Voluson S10 Voluson S8t Voluson S10 Expert Voluson S8 IC9B-RS Voluson S6 L2-9-D ML4-20VN-D L2-9VN-D LOGIQ E10s C2-9VN-D ML4-20-D L8-18i-D BE9CS-D 12S-D LOGIQ E10 Deep Learning Image Reconstruction 6VT-D Vivid S70N C1-5-D Vivid S60N 11L-D 9L-D 10T-D 4Vc-D Voluson E8 Voluson E series BT15 Voluson E6 RSP6-16-D Voluson E10 C4-8-D eM6C RNA5-9-D RAB2-5-D RIC6-12-D RM6C Voluson E series LOGIQ F8 Expert LOGIQ F6 LOGIQ F8 iC5-9-D 8C 9T Vivid E90 4V-D Vivid E95 Vivid E80 6Vc-D Versana Balance Vivid iq Versana Premier True Definitional DL Revolution UPG 5 LOGIQ E9 M6C-D 3CRF RAB4-8-D LOGIQ E9 XDClear 2 S4-10-D LOGIQ S8 LOGIQ Fortis 4D ICE catheter LOGIQ e NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L eM6CG2 IC9-D Voluson E series BT16 Voluson E6 BT16 Voluson E10 BT16 Voluson E8 BT16 LOGIQ S20 LOGIQ S20 Express LOGIQ Vita Power LOGIQ Vita Express LOGIQ S20 Plus LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power LOGIQ Vita LOGIQ Vita Pro L12n-RS Venue Venue Trident Vivid Pioneer 9VT-D 6Sc-D 10-D Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Vivid T8 T9 v206 to v208 SW only UPG C2-9-D Probe C2-9-D Transducer eM6C G2 RIC10-D RM7C eM6C G3 Voluson Expert 20 Voluson Expert 22 RAB7-D RIC12-D Voluson Expert 18 Voluson P6 Voluson P8 E8Cs-RS (only for Vivid T9) C1-5-RS (only for Vivid T9) Optima CT660SE Optima CT660ProJ Optima CT660FREEdom Optima CT660Pro Optima CT660sPro Optima CT660J Optima CT660 Revolution EVO 33 kW/48 kW Optima CT660s Revolution EVO Revolution EVO EL Revolution EVO ES Revolution EVO EX Optima CT680 Expert Optima CT680 Quantum Optima CT 670 Optima CT680 Professional CT660 Cj2.5 Upgrade Console Generation Upgrade 12L-SC 4C-SC 3S-SC L8-18i-SC Venue 50 E8CS-SC MTZ Biopsy Guide Attachment E8C Reusable Guide Attachment ERB7/ERB Biopsy Attachment LOGIQ F Versana Premier Lotus Enhanced Extream Injector Option Extream Injector Option Versana Active RT Refresh Package Discovery RT SmartMAR Optima RT OPTIMA CT580 OPTIMA CT580 W OPTIMA CT580 RT Revolution RT DISCOVERY CT590 RT LOGIQ P7 Vivid S70N Dimension LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade LOGIQ E10s R2R3 to R4 HW Upgrade W 6Tc Vivid S70 Vivid S60 Voluson S6 BT16 RAB6-RS Voluson S series Voluson S8 BT16 Voluson S series BT16 Voluson S10 BT16 Voluson E8 Expert SP10-16-D 3S-D RSM5-14 RM14L PA6-8-D RAM3-8 Probe ASiR-V 9L t739 ERB 11L 4C E8C E8CS LOGIQ e NextGen NextGen LOGIQ e C1-6-D Probe LOGIQ E10s R2 to R3 UPG Versana Essential Venue Sprint L12n-SC LOGIQ V5 LOGIQ V5 Expert LOGIQ V3 ML6-15 BE9CS LOGIQ S7 Expert Voluson SWIFT Voluson SWIFT+ Voluson Performance 18 Voluson Performance 16 Voluson Signature 20 Voluson Signature 18 Revolution Ascend EL Revolution Ascend ES Revolution Ascend EX Revolution Ascend Revolution Ascend Plus Revolution Ascend Elite Revolution Ascend Select

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility