Search Results
Found 4 results
510(k) Data Aggregation
K Number
K972520Device Name
OPTIVIEW
Manufacturer
Date Cleared
1997-09-29
(84 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
OPTIMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
Device Description
OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
Ask a Question
Ask a specific question about this device
K Number
K955274Device Name
BOOSTER LITE 3 MOTORIZED SCOOTER
Manufacturer
Date Cleared
1996-11-04
(355 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
OPTIMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K955275Device Name
BOOSTER TROPHY 5 MOTORIZED SCOOTER
Manufacturer
Date Cleared
1996-11-04
(355 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
OPTIMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K955276Device Name
BOOSTER LITE 4 MOTORIZED SCOOTER
Manufacturer
Date Cleared
1996-11-04
(355 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
OPTIMED TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1