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Found 3 results
510(k) Data Aggregation
K Number
K020995Device Name
EFILM WORKSTATION WITH MODULES
Manufacturer
EFILM MEDICAL, INC.
Date Cleared
2002-04-12
(15 days)
Product Code
LLZ, REQ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EFILM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Device Description
eFilm Workstation with Modules is one of the components of a PACS (Picture Archiving and Communications System). eFilm Workstation with Modules is a software application that provides image viewing and manipulation in a diagnostic imaging setting. The functions of this application image viewing and manipadian in are acquired and stored on an image server in DICOM and/or other proprietary formats. eFilm Workstation with Modules can also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
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K Number
K013631Device Name
EFILM VIDEO
Manufacturer
EFILM MEDICAL, INC.
Date Cleared
2001-11-20
(15 days)
Product Code
LMA
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
EFILM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images.
Device Description
eFilm Video™ is a software application that is used for capturing video streams from analogue medical image acquisition devices with video outputs and converting these streams to DICOM modiant cine loops. Users may capture single stills or consecutive images and save them as DICOM files that can be viewed and manipulated in a picture archiving and communications viewing application.
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K Number
K012211Device Name
EFILM WORKSTATION
Manufacturer
EFILM MEDICAL, INC.
Date Cleared
2001-07-31
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EFILM MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Device Description
eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
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