Imation SE-204 Laser Imager

FDA 510(k) K972822 · Imation Enterprises Corp.

Substantially Equivalent

510(k) numberK972822

Submission

Device name
Imation SE-204 Laser Imager
Applicant
Imation Enterprises Corp.
St. Paul, MN, US
Received
July 30, 1997
Decision date
November 19, 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
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 Imation SE-204 Laser Imager cleared by the FDA?

Imation SE-204 Laser Imager (K972822) received a 510(k) decision of Substantially Equivalent on November 19, 1997, 112 days after the submission was received.

What is the product code of K972822?

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