Smart Motorized Viewer

FDA 510(k) K973965 · Smartlight, Ltd.

Substantially Equivalent

510(k) numberK973965

Submission

Device name
Smart Motorized Viewer
Applicant
Smartlight, Ltd.
Nesher, IL
Received
October 17, 1997
Decision date
December 12, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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More from Diversified Diagnostic Products, Inc.

510(k)DeviceDecision
K991302Smartlight Digital Film Viewer, Models SL 4000PLUS, SL 2000PLUSIXC · Traditional 06/01/1999SE

Questions and answers

When was Smart Motorized Viewer cleared by the FDA?

Smart Motorized Viewer (K973965) received a 510(k) decision of Substantially Equivalent on December 12, 1997, 56 days after the submission was received.

What is the product code of K973965?

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