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Jun 4, 2024

IRadimed 3880 MRI Patient Monitoring System AI

.PDF | 739.70 KB

Privacy impact assessment for the 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) environment by trained healthcare professionals.

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Jun 4, 2024

MagView Mammography Information System MMIS

.PDF | 664.12 KB

Privacy impact assessment for the MagView Mammography Information System (MMIS) is a commercial-off-the-shelf (COTS) product. The Magview information software is an automated workflow efficiency tool used for mammography practice.

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Jun 4, 2024

Keller ACH West Point MEDCOI

.PDF | 740.48 KB

Privacy impact assessment for the Keller ACH -West Point_MEDCOI Enclave consists of hardware, software, and telecommunications architecture to provide information services to the hospital and outpatient clinics located at Keller Army Community Hospital in West Point, NY.

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Jun 4, 2024

DiaSorin Liaison XL V4X

.PDF | 738.55 KB

Privacy impact assessment for the DiaSorin Liaison XL V4.X is a fully-automated continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis on human serum or plasma

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Jun 4, 2024

Carestream 9600 Panoramic Dental Xray Version 1X AI

.PDF | 749.90 KB

Privacy impact assessment for the Carestream 9600 Panoramic Dental Xray Version 1.X_AI _(CS9600) is an extra-oral system intended to produce two-dimensional and three-dimensional digital of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for ...

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May 7, 2024

Roche Diagnostics CoaguChek XS Plus Pro System AI

.PDF | 752.38 KB

Privacy impact assessment for The Roche CoaguChek® XS Plus/XS Pro system (CoaguChek XS Plus/XS Pro meter and CoaguChek XS PT Test strips) (enterprise) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood).

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May 7, 2024

Siemens CLINITEK Advantus Series Analyzers AI

.PDF | 746.81 KB

Privacy impact assessment for The Siemens CLINITEK Advantus Series is a semi-automated urine chemistry analyzer. Tests measured include Leukocyte, Nitrite, Protein, Blood, Glucose, Ketone, Bilirubin, Urobilinogen, pH, Specific Gravity, Creatinine, and Protein-to-Creatinine Ratio.

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May 7, 2024

Philips Healthcare PageWriter TC5O TC70 Cardiograph AI

.PDF | 725.18 KB

Privacy impact assessment for The Philips PageWriter TC50/TC70 Cardiograph is designed to simplify diagnostic electrocardiograph testing and streamline workflow by delivering high-quality clinical reports

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May 7, 2024

Siemens Medical Solutions Dimension Vista 500 3 X AI

.PDF | 727.89 KB

Privacy impact assessment for The Siemens Medical Solutions Dimension Vista 500 3.X (AI) is a medical device (Intelligent Lab System). Externally it is a single large unit (7’ in width). Internally it contains one or more analyzers, and an information processing unit.

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May 7, 2024

Public Health Command Europe PHCE

.PDF | 723.85 KB

Privacy impact assessment for Public Health Command Europe is a Brigade size component supporting over 54,000 overseas personnel in the Kaiserslautern Community area with services such as Veterinary services for family pets and military working dogs, a multitude of laboratory services to ensure community health,

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May 7, 2024

316th Med Group Joint Base Andrews MEDCOI

.PDF | 746.41 KB

Privacy impact assessment for the The 316th Medical Group Joint Base Andrews MEDCOI Enclave will provide core services to the medical center's enterprise to include collections of storage arrays, networking infrastructure, backup/recovery devices, virtual server infrastructure, physical servers.

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May 7, 2024

Beckman Coulter DXH 800 600 Series Analyzer V3 X AI

.PDF | 748.74 KB

Privacy impact assessment for the Beckman Coulter DXH 800/600 Series Analyzer V3.X AI employ Automated Intelligent Morphology, this enhanced multidimensional high-definition cellular analysis solution utilizes flow cytometric technology to deliver results to physicians and patients faster and with greater confidence.

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May 7, 2024

Naval Hospital Pensacola MEDCOI

.PDF | 750.19 KB

Privacy impact assessment for The Naval Hospital Pensacola MEDCOI Local Area Network consists of hardware, software, and telecommunications architecture to provide information services to the hospital and outpatient clinics located at Navy Medicine Readiness and Training Command Pensacola.

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May 7, 2024

Nuance PowerScribe 360 v4 Voice Dictation System

.PDF | 747.78 KB

Privacy impact assessment for Nuance PowerScribe 360 v4 Voice Dictation System (PS360V4) is a voice recognition system that is used in radiology departments to facilitate dictation and reporting of radiology studies.

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May 7, 2024

Philips Magnetic Resonance Imaging Family Version R5 X AI

.PDF | 739.49 KB

Privacy impact assessment for the Philips Magnetic Resonance Imaging Family Version R5.X_AI medical devices (within the limits of the used Examination Room table) is intended for use as a diagnostic device.

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