Gammaloc System, Model 03-00001

FDA 510(k) K082588 · Dilon Technologies, LLC

Substantially Equivalent

510(k) numberK082588

Submission

Device name
Gammaloc System, Model 03-00001
Applicant
Dilon Technologies, LLC
Newport News, VA, US
Received
September 8, 2008
Decision date
December 11, 2009
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 Gammaloc System, Model 03-00001 cleared by the FDA?

Gammaloc System, Model 03-00001 (K082588) received a 510(k) decision of Substantially Equivalent on December 11, 2009, 459 days after the submission was received.

What is the product code of K082588?

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