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    K Number
    K250284
    Device Name
    TSK SELECT™ Needle
    Manufacturer
    TSK Laboratory, Japan
    Date Cleared
    2025-07-24

    (174 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TSK Laboratory, Japan

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K244018
    Device Name
    Disposable Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-07-22

    (207 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang CuraWay Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250913
    Device Name
    TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
    Manufacturer
    Jiangsu Tingsn Technology Co., Ltd.
    Date Cleared
    2025-07-19

    (114 days)

    Product Code
    IYN, IYO, OBJ
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Tingsn Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250185
    Device Name
    Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
    Manufacturer
    Jiangxi AICARE Medical Technology Co., Ltd.
    Date Cleared
    2025-07-14

    (173 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangxi AICARE Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251830
    Device Name
    Sonosite LX Ultrasound System
    Manufacturer
    FUJIFILM Sonosite, Inc.
    Date Cleared
    2025-07-10

    (27 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJIFILM Sonosite, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250065
    Device Name
    DENSITY; DENZA; DENSITY Noir
    Manufacturer
    Jeisys Medical Incorporated
    Date Cleared
    2025-07-08

    (179 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jeisys Medical Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243468
    Device Name
    Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
    Manufacturer
    JOYTECH Healthcare Co., Ltd.
    Date Cleared
    2025-07-02

    (236 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOYTECH Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251285
    Device Name
    Electric Wheelchair (HG-630)
    Manufacturer
    Zhejiang Automwheel Tech Co., Ltd.
    Date Cleared
    2025-07-02

    (68 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang Automwheel Tech Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243690
    Device Name
    SonoMSK
    Manufacturer
    PAJUNK GmbH Medizintechnologie
    Date Cleared
    2025-07-01

    (214 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAJUNK GmbH Medizintechnologie

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243647
    Device Name
    Synapse PACS (7.5)
    Manufacturer
    FUJIFILM Healthcare Americas Corporation
    Date Cleared
    2025-06-30

    (216 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    FUJIFILM Healthcare Americas Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: - Performing measurements on DICOM images - Regional segmentation - Importing and presenting data from modalities (DICOM and non-DICOM), - Solving clinical calculations - Creating and distributing structured reports FUJIFILM Synapse PACS Software is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. It enables the display, comparison, fusion, and volume rendering of studies to aid in reading, interpreting, reporting, and treatment planning. MIP, MPR Fusion, and volume rendering are not intended for mammography use. FUJIFILM Synapse PACS Software can be used to process FUJIFILM's DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA-cleared, DICOM compatible displays for mammography.
    Device Description
    The Synapse PACS is an enterprise-wide medical information and image management software that runs on standard "off-the-shelf" PC hardware and Software (OS, browser). Synapse is intended for communication, storage, display, manipulation, measurement, printing, and processing of images and information acquired from various medical imaging and information systems. As a Software as a Medical Device (SaMD), Synapse PACS performs these purposes without being part of a hardware medical device. FUJIFILM Synapse PACS Software is intended for use as a web-based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. The FUJIFILM Synapse PACS Software can process medical images from DICOM compliant modalities and non-DICOM sources. FUJIFILM Synapse PACS Software provides toolsets for: - Performing measurements on DICOM images - Regional segmentation - Importing and presenting data from modalities (DICOM and non-DICOM), - Solving clinical calculations - Creating and distributing structured reports
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