FDA 510(k)

GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER

K-Number: K012775 · 2001-09-18

Decision Date2001-09-18

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2001-09-18 under 510(k) number K012775. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER?

GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER is a medical device that received FDA 510(k) clearance on 2001-09-18. The listed applicant is GE Medical Systems. The 510(k) number is K012775.

When did GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER receive FDA 510(k) clearance?

GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER received FDA 510(k) clearance on 2001-09-18, under 510(k) number K012775.

Who is the listed applicant for GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER?

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

What is the FDA product code for GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER?

The FDA product code for GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER is KPS.

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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.