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FDA 510(k)

SYNGO BODY PERFUSION-CT

K-Number: K050867 · 2005-04-14

ApplicantSiemens AG
Decision Date2005-04-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO BODY PERFUSION-CT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG. It received FDA 510(k) clearance on 2005-04-14 under 510(k) number K050867. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNGO BODY PERFUSION-CT?

SYNGO BODY PERFUSION-CT is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Siemens AG. The 510(k) number is K050867.

When did SYNGO BODY PERFUSION-CT receive FDA 510(k) clearance?

SYNGO BODY PERFUSION-CT received FDA 510(k) clearance on 2005-04-14, under 510(k) number K050867.

Who is the listed applicant for SYNGO BODY PERFUSION-CT?

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

What is the FDA product code for SYNGO BODY PERFUSION-CT?

The FDA product code for SYNGO BODY PERFUSION-CT is JAK.

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Other records listing Siemens AG as applicant

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.

K123375SYNGO.VIAK110366SYNGO.CT CARDIAC FUNCTIONK071310SYNGO CT ONCOLOGY SOFTWARE PACKAGEK063507SYNGO NEURO PBV CTK063373FLEX LOOP COIL SET 3TK053024SYNGO NEURO DSA CT

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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