BEUDAMED
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    GMK Sphere Revision

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIAZYME CYSTATIN C POC TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMAGER II ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATROL

    FDA Adverse Event
    Malfunction ·ABBOTT NUTRITION·Product code LZH·October 20, 2008

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·August 15, 2011

    IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVZ·July 8, 2013

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2012

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·March 15, 2013

    IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 5, 2011

    NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed quickly and effortlessly with a simple touch screen. In-room integration provides a more convenient workflow for the radiographer throughout the imaging process. NX communicates seamlessly with the hospital's picture archiving and communication system (PACS), radiology information system (RIS) and hospital information system (HIS). It is DICOM compliant and meets IHE guidelines.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·March 4, 2011

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 30, 2014

    19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·June 30, 2010

    Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·January 27, 2011

    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·January 16, 2012

    IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·March 21, 2011

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025