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510(k) Data Aggregation
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
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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