BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SYNGO.X

    FDA 510(k)
    FDA Class 2 ·Radiology

    Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·March 6, 2017

    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·March 6, 2017

    Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 5, 2017

    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 5, 2017

    ARTHROCARE ELECTROSURGERY WANDS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VITREA 2, VERSION 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    1213809-2018-00490

    FDA Adverse Event
    Malfunction ·August 6, 2018

    2520274-2013-02362

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·May 3, 2013

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 16, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·May 2, 2011

    AMISTEM H, HA COATED STEM SIZE 2 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 3, 2017

    MULTIPLE-SEE ATTACHED

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code OAD·March 24, 2009

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012