Lumagem Scintillation Camera

FDA 510(k) K993813 · Gamma Medica

Substantially Equivalent

510(k) numberK993813

Submission

Device name
Lumagem Scintillation Camera
Applicant
Gamma Medica
Northridge, CA, US
Received
November 10, 1999
Decision date
January 18, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IYX – Camera, Scintillation (Gamma)
Device class
Class I (low risk)
Regulation
21 CFR 892.1100
Specialty
Radiology

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Questions and answers

When was Lumagem Scintillation Camera cleared by the FDA?

Lumagem Scintillation Camera (K993813) received a 510(k) decision of Substantially Equivalent on January 18, 2000, 69 days after the submission was received.

What is the product code of K993813?

The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.