Modular Daylight Cassette for Video Imaging

FDA 510(k) K953477 · The DU Pont Co.

Substantially Equivalent

510(k) numberK953477

Submission

Device name
Modular Daylight Cassette for Video Imaging
Applicant
The DU Pont Co.
Wilmington, DE, US
Received
July 24, 1995
Decision date
October 7, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LMC – Camera, Multi Format, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2040
Specialty
Radiology

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Questions and answers

When was Modular Daylight Cassette for Video Imaging cleared by the FDA?

Modular Daylight Cassette for Video Imaging (K953477) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 75 days after the submission was received.

What is the product code of K953477?

The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.