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FDA 510(k)

ADVANTAGE WINDOWS CT/PET FUSION

K-Number: K010336 · 2001-02-16

ApplicantGe Medical Systems, Inc.
Decision Date2001-02-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE WINDOWS CT/PET FUSION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-02-16 under 510(k) number K010336. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE WINDOWS CT/PET FUSION?

ADVANTAGE WINDOWS CT/PET FUSION is a medical device that received FDA 510(k) clearance on 2001-02-16. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K010336.

When did ADVANTAGE WINDOWS CT/PET FUSION receive FDA 510(k) clearance?

ADVANTAGE WINDOWS CT/PET FUSION received FDA 510(k) clearance on 2001-02-16, under 510(k) number K010336.

Who is the listed applicant for ADVANTAGE WINDOWS CT/PET FUSION?

The FDA 510(k) record lists Ge Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANTAGE WINDOWS CT/PET FUSION?

The FDA product code for ADVANTAGE WINDOWS CT/PET FUSION is LLZ.

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Official Source

View on FDA Database →

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

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