FDA 510(k)

BIOGRAPH 16 TRUE POINT SYSTEMS

K-Number: K083852 · 2009-03-23

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2009-03-23

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIOGRAPH 16 TRUE POINT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K083852. 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 BIOGRAPH 16 TRUE POINT SYSTEMS?

BIOGRAPH 16 TRUE POINT SYSTEMS is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K083852.

When did BIOGRAPH 16 TRUE POINT SYSTEMS receive FDA 510(k) clearance?

BIOGRAPH 16 TRUE POINT SYSTEMS received FDA 510(k) clearance on 2009-03-23, under 510(k) number K083852.

Who is the listed applicant for BIOGRAPH 16 TRUE POINT SYSTEMS?

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

What is the FDA product code for BIOGRAPH 16 TRUE POINT SYSTEMS?

The FDA product code for BIOGRAPH 16 TRUE POINT SYSTEMS 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.