Product Code: IXC FDA class 1 21 CFR 892.1890

Illuminator, Radiographic-Film

Radiology

A radiographic film illuminator, also known as a viewbox or negatoscope, is a device that provides uniform backlighting to enable diagnostic interpretation of radiographic films by clinicians in a darkened or subdued light environment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IXC, regulated under 21 CFR 892.1890, within the Radiology medical specialty.

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FEI Numbers

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Basic Information

Product Code: IXC
Device Class: FDA class 1
Regulation Number: 892.1890
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K991302	SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS	Jun 01, 1999	Substantially Equivalent	Smartlight, Inc.
K973965	SMART MOTORIZED VIEWER	Dec 12, 1997	Substantially Equivalent	Smartlight, Ltd.
K973115	ARRIPRO 35 ST/TV	Sep 02, 1997	Substantially Equivalent	Arnold & Richter Cine Technik
K970240	DIFFUSER PANEL	Mar 11, 1997	Substantially Equivalent	Focused Viewer, Inc.
K954998	LILY DARK VIEWER	Jan 29, 1996	Substantially Equivalent	Lily Imaging Solutions Co.
K954199	VOXBOX	Sep 29, 1995	Substantially Equivalent	Voxel
K952188	ADVIEWER 2000	May 30, 1995	Substantially Equivalent	Adp , Ltd.
K922848	ULTRALITE X-RAY FILM ILLUMINATOR	Sep 28, 1992	Substantially Equivalent	A & S Trading Co.
K922079	ROTOLUX, SELECTOLUX, SHUTTERVUE	Jun 16, 1992	Substantially Equivalent	American Medical Sales, Inc.
K883702	EXCELVIEW ILLUMINATOR	Sep 19, 1988	Substantially Equivalent	Excel Medical Products, Inc.
K875233	VARIVIEWER (X-RAY FILM VIEWER)	Jan 19, 1988	Substantially Equivalent	Diversified Diagnostic Products, Inc.
K872245	PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM	Jun 19, 1987	Substantially Equivalent	General Electric Co.
K854933	SANDHILL ELECTRONIC CALIPER	Feb 12, 1986	Substantially Equivalent	Sandhill
K840607	LF MOTORIZED RADIOGRAPHIC FILM VIEWER	Mar 05, 1984	Substantially Equivalent	Sybron Corp.
K812152	MEDI VIEW	Sep 09, 1981	Substantially Equivalent	Medical Synergy
K802217	VIEW-LITE, MODEL-SL	Oct 23, 1980	Substantially Equivalent	Med-Western Electronics, Inc.
K802216	VIEW-LITE, MODEL-DL	Oct 23, 1980	Substantially Equivalent	Med-Western Electronics, Inc.
K802215	VIEW-LITE, MODEL-S	Oct 23, 1980	Substantially Equivalent	Med-Western Electronics, Inc.