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FDA 510(k)

GAMMALOC SYSTEM, MODEL 03-00001

K-Number: K082588 · 2009-12-11

ApplicantDilon Technologies, LLC
Decision Date2009-12-11
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMALOC SYSTEM, MODEL 03-00001 is the device name listed in this FDA 510(k) record. The listed applicant is Dilon Technologies, LLC. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K082588. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMALOC SYSTEM, MODEL 03-00001?

GAMMALOC SYSTEM, MODEL 03-00001 is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Dilon Technologies, LLC. The 510(k) number is K082588.

When did GAMMALOC SYSTEM, MODEL 03-00001 receive FDA 510(k) clearance?

GAMMALOC SYSTEM, MODEL 03-00001 received FDA 510(k) clearance on 2009-12-11, under 510(k) number K082588.

Who is the listed applicant for GAMMALOC SYSTEM, MODEL 03-00001?

The FDA 510(k) record lists Dilon Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMALOC SYSTEM, MODEL 03-00001?

The FDA product code for GAMMALOC SYSTEM, MODEL 03-00001 is IYX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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