DIFFUSER PANEL

K970240 · Focused Viewer, Inc. · IXC · Mar 11, 1997 · Radiology

Device Facts

• Record ID: K970240
• Device Name: DIFFUSER PANEL
• Applicant: Focused Viewer, Inc.
• Product Code: IXC · Radiology
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1890
• Device Class: Class 1

Indications for Use

The Diffuser Panel is designed to diffuse the light from the light source in Radiographic Film Illuminators.

Device Story

Diffuser Panel functions as a component for radiographic film illuminators; consists of light diffusing layers, brightness enhancer films, and a scratch-resistant polycarbonate cover. Device installed in illuminator housing; operates by diffusing light from internal source to provide uniform illumination across x-ray film. Used in clinical settings by radiologists or clinicians to facilitate diagnostic review of radiographic images. Provides consistent light distribution to aid visual interpretation of films.

Clinical Evidence

No clinical data; bench testing only. Equivalence based on functional comparison of light diffusion and distribution characteristics.

Technological Characteristics

Components: light diffusing films, brightness enhancer films, scratch-resistant polycarbonate panel. Function: light diffusion and uniform distribution. Form factor: panel insert for radiographic film illuminators.

Indications for Use

Indicated for use as a component in radiographic film illuminators to diffuse and evenly distribute light across x-ray film for clinical viewing.

Regulatory Classification

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.

Predicate Devices

• Diversified Diagnostic Products Radiographic Film Illuminator panel (K875233)

Submission Summary (Full Text)

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K970240
MAR 11 1997
Focused Viewer, Inc.
Radiographic Film Illuminator
510(k) Notification

# 510(k) SUMMARY

1. 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: [phone]
Fax: [phone]

Summary was prepared on January 14, 1997.

2. Name of device

Trade/Proprietary Name: Diffuser Panel
Common/Usual Names: Translucent front of a Radiographic Film Illuminator
Classification Name: Radiographic Film Illuminator (21 CFR 892.1890)

3. Legally Marketed Equivalent Device Name

We are claiming substantial equivalence to the panel marketed by Diversified Diagnostic Products. Refer to K875233.

Original 510(k).
January, 1997.
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Focused Viewer, Inc.
Radiographic Film Illuminator
510(k) Notification

# 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 from 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 Brauer, M.D.
Owner
Focused Viewer, Inc.

JAN 21, 1997
Date

Original 510(k).
January, 1997.