Search Results
Found 3 results
510(k) Data Aggregation
K Number
K110006Device Name
OIS SYMPHONY IMAGE MANAGMENT SYSTEM
Manufacturer
OPHTHALMIC IMAGING SYSTEMS
Date Cleared
2011-05-18
(135 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OIS Symphony is a comprehensive software platform for the import, integration and review of patient data and clinical information in an eye care environment. OIS Symphony allows for the collection, management, enhancement and review of the patient demographics, image data, diagnostic data and clinical reports from a variety of medical devices through either a direct connection with the instruments or through computerized networks.
Device Description
The OIS Symphony System is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. OIS Symphony consists of image display via Symphony Web, Image Import via Symphony Import and integration of imaging performed in OIS WinStation.
OIS Symphony is a software solution consistent with the predicate devices listed herein, using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment.
Symphony provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
Ask a Question
K Number
K092374Device Name
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
Manufacturer
OPHTHALMIC IMAGING SYSTEMS
Date Cleared
2009-11-17
(104 days)
Product Code
HKI, HJO, NFG
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OIS EyeScan Portable Modular Imaging System is a portable monocular camera intended for imaging of both the posterior segment (including structures of the retina, vitreous and choroid) and anterior segment (including structures of the orbit, lids, cornea, iris and lens) of the eye. The device is suitable for documentation of findings in a clinical setting.
Device Description
OIS EyeScan is a portable, modular imaging device, which is designed to perform retinal imaging (including color, FA, FAF, Red-free) and corneal imaging (including tear film analysis, corneal fluorescences, slit). OIS EyeScan Portable Modular Imaging System, consistent with the predicate imaging devices previously listed, uses light photography to obtain clinical information. OIS EyeScan captures images using light sources (LEDs of different colors), functionally optimized lenses and filters, and digital camera sensors. OIS EyeScan uses OIS WinStation software for image capture, review and analysis. The device comprises a base unit, and interchangeable imaging modules and optional chin rest. Images may be stored on industry standard storage media.
Ask a Question
K Number
K982689Device Name
WINSTATION RETINAL IMAGER
Manufacturer
OPHTHALMIC IMAGING SYSTEMS
Date Cleared
1998-10-23
(81 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
OPHTHALMIC IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WinStation Retinal Imager™ has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segment (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
Device Description
Not Found
Ask a Question
Page 1 of 1