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510(k) Data Aggregation
K Number
K991302Device Name
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
Manufacturer
Date Cleared
1999-06-01
(46 days)
Product Code
Regulation Number
892.1890Why did this record match?
Product Code :
IXC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SmartLight Digital Film Viewer System is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The Digital Film Viewer is a radiographic film illuminator with the following new indications for use:
- The Digital Film Viewer substantially improves the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes.
- The Digital Film Viewer substantially improves the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes.
- The Digital Film Viewer mitigates the age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
Device Description
The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films.
The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below:
- Adaptive Light Intensity The device automatically adapts the intensity of the back illumination system according to film density. Back light intensity ranges from 500-10,000 nits.
- Masking The device enables electro-optical collimation of the back illumination such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare.
- Film Scatter Suppression The device incorporates an optical grid, which projects light in the forward direction to suppress optical scatter within the film (Callier effect).
- Ambient Light The device reduces the ambient light level when films are mounted on its faceplate.
- Pupil Diameter The device emits a dark blue light from its faceplate to control pupil dilation.
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K Number
K973965Device Name
SMART MOTORIZED VIEWER
Manufacturer
Date Cleared
1997-12-12
(56 days)
Product Code
Regulation Number
892.1890Why did this record match?
Product Code :
IXC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Radiographic Film Reading
Device Description
The SL800001 is a motorized radiographic film illuminator which enables electro-optical masking of the back illumination in such a way that those parts of the face plate which are covered by films are illuminated, and exposed parts of the face plate are masked (dark). The SL80000 is designed to minimize problems which are associated with glare induced degradation of visual perception capacity and fatigue of film readers. The SL800000 is is comprised of a motorized belt assembly, fluorescent backlight assembly, electro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software.
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K Number
K973115Device Name
ARRIPRO 35 ST/TV
Manufacturer
Date Cleared
1997-09-02
(13 days)
Product Code
Regulation Number
892.1890Why did this record match?
Product Code :
IXC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.
The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.
The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.
Device Description
The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.
The ARRIPRO 35 St / TV has the following functions: Rapid Film Transport and Simple Operation, Optimized Image Quality with Flicker Free Projection, High Speed Shuttle, Revolving Lamp Holder, Optimum Wall Projection, Computer and Video Connections, B&W-CCD-TV Camera.
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K Number
K970240Device Name
DIFFUSER PANEL
Manufacturer
Date Cleared
1997-03-11
(48 days)
Product Code
Regulation Number
892.1890Why did this record match?
Product Code :
IXC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.
Device Description
The Diffuser Panel consists of layers of light diffusing and brightness enhancer films, plus a clear polycarbonate panel that is coated with a scratch guard to protect the surface of the brightness enhancer from scratching.
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K Number
K954998Device Name
LILY DARK VIEWER
Manufacturer
Date Cleared
1996-01-29
(89 days)
Product Code
Regulation Number
892.1890Why did this record match?
Product Code :
IXC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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