Frantz Imaging Compact Camera

FDA 510(k) K871959 · Frantz Imaging, Inc.

Substantially Equivalent

510(k) numberK871959

Submission

Device name
Frantz Imaging Compact Camera
Applicant
Frantz Imaging, Inc.
Irvine, CA, US
Received
May 20, 1987
Decision date
June 22, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Frantz Imaging Compact Camera cleared by the FDA?

Frantz Imaging Compact Camera (K871959) received a 510(k) decision of Substantially Equivalent on June 22, 1987, 33 days after the submission was received.

What is the product code of K871959?

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