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FDA 510(k)

SYNGO.CT CARDIAC FUNCTION

K-Number: K110366 · 2011-04-12

ApplicantSiemens AG
Decision Date2011-04-12
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO.CT CARDIAC FUNCTION is the device name listed in this FDA 510(k) record. The listed applicant is Siemens AG. It received FDA 510(k) clearance on 2011-04-12 under 510(k) number K110366. 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.CT CARDIAC FUNCTION?

SYNGO.CT CARDIAC FUNCTION is a medical device that received FDA 510(k) clearance on 2011-04-12. The listed applicant is Siemens AG. The 510(k) number is K110366.

When did SYNGO.CT CARDIAC FUNCTION receive FDA 510(k) clearance?

SYNGO.CT CARDIAC FUNCTION received FDA 510(k) clearance on 2011-04-12, under 510(k) number K110366.

Who is the listed applicant for SYNGO.CT CARDIAC FUNCTION?

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.CT CARDIAC FUNCTION?

The FDA product code for SYNGO.CT CARDIAC FUNCTION 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.VIAK071310SYNGO CT ONCOLOGY SOFTWARE PACKAGEK063507SYNGO NEURO PBV CTK063373FLEX LOOP COIL SET 3TK053024SYNGO NEURO DSA CTK050867SYNGO BODY PERFUSION-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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