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510(k) Data Aggregation
K Number
K233841Device Name
HD80 Series Ultrasound Diagnostic System
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd
Date Cleared
2024-05-16
(164 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD80 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD80 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Device Description
The HD80 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD80 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.
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K Number
K233439Device Name
HD60 Series Ultrasound Diagnostic System
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd
Date Cleared
2024-02-21
(128 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode. B. M. PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/Color/PWD or CWD, B/Power/PWD.
Device Description
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.
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K Number
K222208Device Name
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd
Date Cleared
2022-11-17
(115 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
Device Description
The Hisense LCD monitors are intended for trained medical practitioners and provides the image viewing and medical diagnostic functions. HMD2C21A, HMD4C27S, HMD6C30D are developed with different resolution:1600 x 1200, 2560 x 1440, 3280 × 2080. So the LCD monitors can be used in different environment according to different resolution requirement. The three models also developed with same features such as energy saving, ambient light induction, front-facing sensor calibration, etc. In particular, HMD4C27S, HMD6C30D have body-inductive energy-saving and auto awake function.
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K Number
K222132Device Name
Hisense LCD monitor HMD2G21S, HMD3G21S
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd
Date Cleared
2022-11-08
(112 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) The 2MP Monochrome LCD Monitor HMD2G21S is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners.
The device does not support the display of mammography images for diagnosis.
2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Device Description
Hisense HMD2G21S, HMD3G21S LCD monitor complies with the DICOM Part 14 standard and is applicable to DSA, MRI, DR, CR, CT, and PET medical imaging. It is intended for trained medical practitioners and provides the image viewing and medical diagnostic functions.
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K Number
K221567Device Name
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd.
Date Cleared
2022-07-26
(56 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Device Description
The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.
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K Number
K213862Device Name
HD60 Series Ultrasound Diagnostic System
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd
Date Cleared
2022-06-08
(180 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, musculo-skeletal (conventional, superficial), cardiac (adult, peripheral vessel, and urology exams.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/ Power/PWD.
Device Description
The HD60 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD60 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN.
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K Number
K152030Device Name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd.
Date Cleared
2015-09-16
(56 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Device Description
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
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K Number
K151709Device Name
Hi-Light Diagnostic Ultrasound Systems
Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd.
Date Cleared
2015-07-17
(23 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Qingdao Hisense Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Device Description
The Hi-Light is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. The modes of operation include B mode.
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