Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019784575

FEI Number

3019784575

Entity Name

FUJIFILM Corporation Medical Systems Research & Development Center Kokubunji

City/State/Country

KOKUBUNJI-SHI Tokyo, JP

Establishment Address

3-1-1 HIGASHIKOIGAKUBO, KOKUBUNJI-SHI Tokyo 185-0014, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM Corporation (Owner Number: 10081521)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, Minato-ku, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163505

PMA Number

N/A

All Registered Proprietary Names

UST-5310 and UST-5311 Prosound Alpha 6 C253 L34 C41RP ARIETTA 50 C42K S11 CC41R L442 C421 L44K VC35 VC41V C253A L64 L53K C41L47RP L51K C35 C22P S31 C23RV/C23 C41B C251 CL4416R1 C22K C25P UST-2265-2 CC41R2 C41V L55 L43K C41V1 C41RP ARIETTA x10 C23RV L31KP L44LA L55 R41R VC35 C35 CC41R2 C421 L53K C41V1 UST-2266-5 C252 S121 S3ESEL L44K L64 C42T CL4416R1 L441 R41R C41V1 L46K1 L55 L44K L44LA1 C22I EUP-L53L C41 L53K L442 S121 L43LAP C41B C41V C25P S11 C22P C23 C421 L35 VC35 SML44 C22T L43KM C42K CC41R L64 C253A C42 C253 S3ESL1 L34 L52H C252 MXS1 C35 R41RL S3ESEL C22K ARIETTA 750 L31KP C41L47RP CL4416R S31 C41RP UST-2265-2 S3ESCLS CL4416R1 VC41V C23RV C42T L51K L44LA S42 S31KP L441 CC41R2 HI VISION ASCENDUS Prosound 6 CL4416R C41L47RP C23 CC41R2 UST-2265-2 L43K C25P VC35 C253 L46K1 S11 C42T R41R C251 L53K L44K UST-2266-5 L52H CL4416R1 VC34 L44LA1 S3ESCLS L31KP L35 VC41V C22K C22P L44LA C41B S31 S121 C252 CC41R S3ESEL L55 L442 C41RP C23RV L441 S42 Aloka Arietta 850 C42 L51K L34 S3ESL1 ARIETTA 850 CC41R1 C42K C41V1 MXS1 R41RL C35 SML44 L64 ARIETTA 70 Prosound Alpha 6 C42K UST-2265-2 C23RV C25P C22P L46K1 C41 R41R S42 L51K L31KP Arietta 65 C22K L43LAP CL4416R CC41R1 S3ESL1 L34 C42T S31 C253A L44K C421 L53K S211 C41RP C35 C22I L55 L441 C41V CL4416R1 C42 R41RL CC41R CC41R2 L64 C41B C253 C251 C41L47RP L43K C41V1 L442 C23 L44LA VC35 VC41V S31KP S11 S3ESEL C252 L44LA ARIETTA Prologue ARIETTA 60 / ARIETTA S60 / ARIETTA V60 Prosound 2 UST-5310 and UST-5311 Prosound Alpha 7, ARIETTA 70 UST-5311 CL4416R L44LA1 C251 L64 UST-5310 C41V R41RL CC41R1 L441 L46K1 ARIETTA Precision C22T C42K C22P C25P L43K L44K CC41R2 L44LA C22i CL4416R1 C42T L51K S31KP C41L47RP L53K

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-07-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-12-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-09-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-09-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-09-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-05-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-05-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-05-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-07-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-04-24
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

Randy Vader Business: FUJIFILM Healthcare Americas Corporation Email: randy.vader@fujifilm.com Phone: (360) 3566821

Related Public Records

Same Entity

FUJIFILM Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018423337	FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa	KASHIWA-SHI Chiba, JP
3032109225	FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office	Kashiwa-shi Chiba, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022	DJO, LLC	2	Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022	Aesthetics Systems Usa Inc	2	Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026	ImaCor Inc.	2	ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019784575. Last updated year: 2026. Please use registration number 3019784575 when referencing this establishment in official correspondence.