Search Results
Found 2 results
510(k) Data Aggregation
K Number
K071894Device Name
XEBRA DICOM IMAGE BROWSER
Manufacturer
Date Cleared
2007-08-16
(38 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Xebra DICOM Image Browser ™ is a software application that is used for viewing medical images. The Xebra Image Viewer receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disk 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, the Xebra Image Viewer can be integrated with an institution's existing HIS, RIS, EMR, or EHR for a fully integrated electronic patient record. Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
Xebra DICOM Image Browser ™ is one of the components of a Picture Archiving and Communications System (PACS). Xebra DICOM Image Browser ™ is a software application that provides image viewing and manipulation in a web browser. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and or other proprietary formats. The device does not contact the patient, nor does it control any life sustaining devices.
Ask a Question
Ask a specific question about this device
K Number
K023671Device Name
AQUEOUS ACRYLIC DISPERSION 28% W/W
Manufacturer
Date Cleared
2002-11-25
(24 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
CHX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient.
Device Description
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Ask a Question
Ask a specific question about this device
Page 1 of 1