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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004297 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 28, 2019