Data / Medical devices / Japan / GE Healthcare Japan Corporation
GE Healthcare Japan Corporation: FDA-registered device maker in HINO-SHI Tokyo, Japan, 120 510(k) clearances
GE Healthcare Japan Corporation is registered with the FDA (registration 9612283) in HINO-SHI Tokyo, Japan. It lists 9 device types. The FDA files 120 510(k) clearances under its listings, the newest dated October 2, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9612283
- FEI number
- 3002808529
- Address
- 7-127, Asahigaoka 4-chome, HINO-SHI Tokyo, Japan, 191-8503
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 24, 2004
- Registered through
- 2027
- Brand names listed
- 10-D, 10L, 10T-D, 11L, 11L-D, 12L, 12L-RS, 12L-SC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Specification developer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Twister, Brace Setting | ITO | 1 | Manufacturer | 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. Newest 100 of 120.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| September 2, 2026 | K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 7, 2026 | K261668 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | accessdata.fda.gov |
| July 30, 2026 | K261835 | LOGIQ Focus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 26, 2026 | K260398 | LOGIQ e | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 24, 2026 | K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 23, 2026 | K253686 | True Definition DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| January 8, 2026 | K253370 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 7, 2026 | K253366 | LOGIQ Fortis | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 24, 2025 | K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251985 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 29, 2025 | K251963 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 25, 2025 | K251322 | Venue; Venue Go; Venue Fit; Venue Sprint | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 10, 2025 | K251169 | Vivid Pioneer | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 29, 2025 | K250543 | Voluson Performance 16; Voluson Performance 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 11, 2025 | K243628 | Vivid T9/Vivid T8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 11, 2025 | K243620 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 20, 2024 | K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 2, 2024 | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240111 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K240053 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 10, 2024 | K234106 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 11, 2024 | K233698 | True Enhance DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| March 7, 2024 | K233692 | Voluson Signature 20, Voluson Signature 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 7, 2023 | K232381 | LOGIQ Totus | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 7, 2023 | K231989 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | accessdata.fda.gov |
| November 7, 2023 | K231966 | LOGIQ E10 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 3, 2023 | K232186 | LOGIQ e | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | accessdata.fda.gov |
| October 30, 2023 | K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 20, 2023 | K230346 | Voluson SWIFT; Voluson SWIFT+ | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC | accessdata.fda.gov |
| April 20, 2023 | K230807 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| February 16, 2023 | K223832 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | Ge Medical System Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 15, 2023 | K223407 | Versana Essential | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 29, 2022 | K220961 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| July 22, 2022 | K220882 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 18, 2022 | K221148 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| July 18, 2022 | K221147 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 15, 2022 | K220619 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 27, 2022 | K220851 | Venue | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 27, 2022 | K220848 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| June 21, 2022 | K220800 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| June 6, 2022 | K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| May 11, 2022 | K220446 | Versana Balance | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 22, 2022 | K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| February 17, 2022 | K213689 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 4, 2022 | K213938 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| January 13, 2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 17, 2021 | K212067 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| September 10, 2021 | K211488 | LOGIQ E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 10, 2021 | K210438 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 27, 2021 | K211524 | LOGIQ E10s, LOGIQ Fortis | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 9, 2021 | K211216 | Vivid S60N / Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 5, 2021 | K202658 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 8, 2021 | K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 29, 2020 | K203137 | Venue Fit | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 20, 2020 | K203169 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| November 18, 2020 | K202233 | Venue Go | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 13, 2020 | K202132 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 11, 2020 | K201828 | Voluson SWIFT, Voluson SWIFT+ | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 9, 2020 | K200851 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 9, 2020 | K200708 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 23, 2020 | K200743 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| July 16, 2020 | K200497 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| July 1, 2020 | K200138 | Versana Premier | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound And | accessdata.fda.gov |
| June 11, 2020 | K200998 | Versana Active | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 1, 2020 | K200119 | LOGIQ E10s | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 13, 2019 | K193170 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| August 29, 2019 | K192159 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 9, 2019 | K191798 | Versana Active | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| August 9, 2019 | K191792 | Versana Balance | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| January 28, 2019 | K183362 | Venue GO | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| December 6, 2018 | K181727 | Vivid iq | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 21, 2018 | K182277 | Versana Premier | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| November 15, 2018 | K181985 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 6, 2018 | K181934 | Vivid T8, Vivid T9 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| October 25, 2018 | K181685 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 19, 2018 | K182450 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| September 20, 2018 | K181783 | LOGIQ P9; LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 2, 2018 | K180599 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 29, 2018 | K180535 | Voluson P6 and Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 13, 2018 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 2, 2017 | K173341 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| September 29, 2017 | K172342 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 21, 2017 | K170714 | Venue | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 14, 2017 | K170878 | Vivid S60N, Vivid S70N | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| June 12, 2017 | K170823 | Vivid E80, Vivid E90, Vivid E95 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| April 11, 2017 | K170445 | LOGIQ S8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 10, 2017 | K163596 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 17, 2016 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| October 3, 2016 | K162269 | Voluson E6, Voluson E8, Voluson E10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 5, 2016 | K161706 | Vivid iq | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | accessdata.fda.gov |
| August 5, 2016 | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| May 5, 2016 | K161047 | LOGIQ P9 and LOGIQ P7 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 26, 2016 | K160162 | Voluson P6, Voluson P8 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 25, 2016 | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
| March 10, 2016 | K160078 | Vivid T8 | IYN | Substantially Equivalent | Ge Medical Systems Ultrasound and Primary Care Diagnotics, L | accessdata.fda.gov |
| February 26, 2016 | K160182 | LOGIQ S7 Expert | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 25, 2016 | K160184 | Voluson S6, Voluson S8, Voluson S10 | IYN | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 4, 2016 | K153037 | LOGIQ V1/ LOGIQ V2 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| November 18, 2015 | K152758 | Venue 50 | IYN | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2018 | 80563 | Class II | Terminated | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Automated Radiological Image Processing Software
- All makers of Twister, Brace Setting
Updated October 2, 2026. 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.