FDA 510(k)

POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

K-Number: K001681 · 2000-08-25

Decision Date2000-08-25

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smv America. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K001681. 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 POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM?

POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Smv America. The 510(k) number is K001681.

When did POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM receive FDA 510(k) clearance?

POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM received FDA 510(k) clearance on 2000-08-25, under 510(k) number K001681.

Who is the listed applicant for POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM?

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

What is the FDA product code for POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM?

The FDA product code for POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM is KPS.

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Other records listing Smv America as applicant

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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.