FDA 510(k)

BIOGRAPH 64 AND BIOGRAPH 40

K-Number: K060631 · 2006-03-17

ApplicantSiemens Medical Solutions USA, Inc.

Decision Date2006-03-17

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BIOGRAPH 64 AND BIOGRAPH 40 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 2006-03-17 under 510(k) number K060631. 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 64 AND BIOGRAPH 40?

BIOGRAPH 64 AND BIOGRAPH 40 is a medical device that received FDA 510(k) clearance on 2006-03-17. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K060631.

When did BIOGRAPH 64 AND BIOGRAPH 40 receive FDA 510(k) clearance?

BIOGRAPH 64 AND BIOGRAPH 40 received FDA 510(k) clearance on 2006-03-17, under 510(k) number K060631.

Who is the listed applicant for BIOGRAPH 64 AND BIOGRAPH 40?

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 64 AND BIOGRAPH 40?

The FDA product code for BIOGRAPH 64 AND BIOGRAPH 40 is KPS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: KPS)

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.