Lily Dark Viewer

FDA 510(k) K954998 · Lily Imaging Solutions Co.

Substantially Equivalent

510(k) numberK954998

Submission

Device name
Lily Dark Viewer
Applicant
Lily Imaging Solutions Co.
Fortuna, CA, US
Received
November 1, 1995
Decision date
January 29, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IXC – Illuminator, Radiographic-Film
Device class
Class I (low risk)
Regulation
21 CFR 892.1890
Specialty
Radiology

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K970240Diffuser PanelIXC · Traditional Focused Viewer, Inc.03/11/1997SE
K954199VoxboxIXC · Traditional Voxel09/29/1995SE
K952188Adviewer 2000IXC · Traditional Adp , Ltd.05/30/1995SE
K922848Ultralite X-Ray Film IlluminatorIXC · Traditional A & S Trading Co.09/28/1992SE
K922079Rotolux, Selectolux, ShuttervueIXC · Traditional American Medical Sales, Inc.06/16/1992SE
K883702Excelview IlluminatorIXC · Traditional Excel Medical Products, Inc.09/19/1988SE
K875233Variviewer (X-Ray Film Viewer)IXC · Traditional Diversified Diagnostic Products, Inc.01/19/1988SE

More from Diversified Diagnostic Products, Inc.

510(k)DeviceDecision
K954999Lily Multicannula GuideKNW · Traditional 04/04/1996SE

Questions and answers

When was Lily Dark Viewer cleared by the FDA?

Lily Dark Viewer (K954998) received a 510(k) decision of Substantially Equivalent on January 29, 1996, 89 days after the submission was received.

What is the product code of K954998?

The FDA product code is IXC – Illuminator, Radiographic-Film, a Class I (low risk) device regulated under 21 CFR 892.1890.