Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016696283

FEI Number

3016696283

Entity Name

Qingdao Hisense Medical Equipment Co.,Ltd.

City/State/Country

Qingdao Shandong, CN

Establishment Address

No. 399 Songling Road, Laoshan District, Qingdao Shandong 266100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Qingdao Hisense Medical Equipment Co.,Ltd. (Owner Number: 10062879)

Owner / Operator Contact Address

No. 399 Songling Road, Laoshan District, Qingdao, CN-SD 266100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221567

PMA Number

N/A

All Registered Proprietary Names

Hisense LCD monitor HMD2G21S, HMD3G21S P4-1E HD35 P4-1EB HD30T HD25E HD60E HD50G HD45 HD20T C5-1E L12-4L HD55Plus HD50 HD30 HD42Q HD40 HD25EXP L15-5EB HD45Q E9-4E HD40Q HD30Q L14-6E HD25Q HD42 L9-3E HD25G HD42S HD42G HD60 HD40E P4-1L HD62Pro MC11-3A HD48Plus HD35S HD20 HD58 L15-5EL L9-3A DC7-2A HD48G ECL11-4E HD58EXP HD58Pro E9-3E SC7-1E SC8-2E E9-4EL HD55E HD45S HD45T HD30E HD30EXP P4-1EL HD55 HD35Plus P5-1A HD20E P8-2EJ HD60S HD50E HD59 HD45E HD20Pro HD20S HD40Plus HD59EXP HD60EXP L12-3EB DC6-2A HD42T HD25Pro E9-4L C5-2A HD50T HD55S HD25T HD40G HD55T HD48E HD59Pro HD30G HD55G HD62EXP HD30S HD25 HD50Q HD62 HD60G HD60Pro HD35G HD50S L12-3E HD20G HD48Q HD59Plus HD45Plus HD48 HD20EXP HD58Plus HD45G HD42E DE10-3E L15-5E HD40S HD42Plus HD35Q HD30Pro HD20Q HD35T HD60T HD60Q HD35E HD55Q HD48S E9-4B HD25S HD40T C5-2L HD62Plus HD50Plus HD48T Hisense 8MP LCD Monitor; HME8C32 Hisense 2MP LCD Monitor; HME2C26 Hisense LCD Monitor; HME8C27 Hisense LCD Monitor; HME8C55U Hisense LCD Monitor; HME8C32E L9-3E L15-5E HD80M HD72G L14-6E HD70 E9-4EL HD75M HD75G HD80Pro L12-3EB HD82 HD70T HD78 HD88EXP HD70S XP5-1E HD82Q HD90Plus HD78Q HD80G C5-1E HD80 HD88S HD82S L15-5EB HD85M E9-4E HD82T HD72S HD82G HD70Q HD82M HD85T HD80S HD90 HD70Pro HD86 ECL11-4E P4-1EL E9-3E HD90EXP HD80Q HD72Plus HD72 HD70G HD85Q HD85Plus HD80T HD88G HD86T HD80Plus HD78Pro HD70EXP HD85E DE10-3E DC7-2E HD86E P4-1EB HD75E HD75Pro HD86S HD78EXP HD78T HD86G HD75T DC7-2A HD90Pro HD85G HD70M HD82Pro HD86Plus HD72EXP SC7-1E HD86Pro HD70E HD80EXP SC8-2E HD72M HD85Pro HD72Pro HD78M HD85 MC11-3A HD78S HD78E HD86M HD78Plus L12-3E HD82E HD86EXP HD88M HD78G HD88T HD75Plus HD82Plus HD88Q HD88 HD75EXP HD72E HD70Plus HD72Q HD80E HD75Q HD75 L21-9E HD88Plus HD82EXP L15-5EL HD85S P5-1A HD85EXP HD72T P8-2EJ HD88E HD88Pro HD75S HD86Q HD35Q HD42 HD42E HD35 HD62 Exp HD40S HD40G L9-3A HD35E HD59 Exp HD35S HD35Plus HD58 Plus HD61 Plus HD62 Pro P8-2E HD58 Exp HD35G P5-1A HD61 HD38 HD38Q MC11-3A HD42G HD60 E9-3E HD61 Exp HD60 Exp HD61 Pro C6-1S HD60 Pro HD40E HD38Plus HD38G HD38T HD40Plus HD40Q HD42S HD62 Plus HD42Q HD38S HD40 HD59 HD35T HD40T HD42Plus HD58 HD42T HD60 Plus HD58 Pro MC9-4A HD38E HD59 Plus HD62 HD59 Pro DC7-2A L12-3E C5-1E DC6-2A P4-1E L15-5E C5-2A E9-4B Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-12-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-02-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-02-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-02-26
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2020-03-12
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-05-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-05-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-05-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-06-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-06-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-06-10
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-12-06
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-09-07

Official Correspondent

Mengmeng Dong

US Agent Details

Wu Ni Email: wu@accshippingcontainers.com Phone: (630) 9950577

Related Public Records

Same Entity

Qingdao Hisense Medical Equipment Co.,Ltd.

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
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
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

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-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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016696283. Last updated year: 2026. Please use registration number 3016696283 when referencing this establishment in official correspondence.