Gamma Camera

FDA 510(k) K780969 · Machlett Laboratories, Inc.

Substantially Equivalent

510(k) numberK780969

Submission

Device name
Gamma Camera
Applicant
Machlett Laboratories, Inc.
Mchenry, IL, US
Received
June 12, 1978
Decision date
June 27, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Gamma Camera cleared by the FDA?

Gamma Camera (K780969) received a 510(k) decision of Substantially Equivalent on June 27, 1978, 15 days after the submission was received.

What is the product code of K780969?

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