(48 days)
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No
The device description and intended use clearly describe a passive optical component (a light diffuser) with no mention of computational processing, algorithms, or learning capabilities.
No
The device is a diffuser panel for radiographic film illuminators, which are used to view images. It does not directly treat or diagnose any medical condition.
No
The device's intended use is to diffuse light in radiographic film illuminators, which are used to view images, not interpret them. It is a component for viewing equipment, not a diagnostic tool itself. The predicate device also does not indicate a diagnostic function.
No
The device description explicitly states it consists of physical components like films and a polycarbonate panel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "diffuse the light source in Radiographic Film Illuminators." This is a function related to the display of medical images (radiographic film), not to the examination of specimens derived from the human body.
- Device Description: The description details the physical components of a light diffusing panel. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening based on biological samples.
The device is a component of a medical imaging system (a radiographic film illuminator), but it does not perform an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1890 Radiographic film illuminator.
(a)
Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
MAR | | 1997
Focused Viewer. Inc Radiographic Film Illuminator 510/k) Notification
510(k) SUMMARY
- Name of submitter, address, phone, fax, contact person and date of summary preparation.
Focused Viewer, Inc. 2420 Pasadena Blvd. Wauwatosa, Wisconsin 53226
The contact person is:
William Brauer, M.D. Owner
Phone: (800)843-9269 Fax: (414)334-8293
Summary was prepared on January 14, 1997.
2. Name of device
Diffuser Panel Trade/Proprietary Name:
Translucent front of a Radiographic Film Illuminator Common/Usual Names:
Radiographic Film Illuminator (21 CFR 892.1890) Classification Name:
3. Legally Marketed Equivalent Device Name
We are claiming substantial equivalence to the panel marketed by Diversified Diagnostic Products. Refer to K875233.
1
Focused Viewer, Inc. Radiographic Film Illuminator
510(k) SUMMARY CONTINUED
4. Description of the device
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.
5. Intended use of the device
The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.
6. Comparison of technological characteristics with predicate device
The function of glass or plastic translucent panels is to diffuse light, and distribute bright light evenly over the x-ray film. The Focused Viewer Diffuser Panel is composed of plastic and is designed to diffuse light and distribute light evenly over the x-ray film in a manner equivalent to marketed devices and to provide at least equivalent brightness.
William R. Brauer JAN 21, 1997
William Brauer, M.D. Owner Focused Viewer, Inc. Date
Original 510(k). January, 1997.