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FDA 510(k)

SOMATOM DEFINITION FLASH

K-Number: K113342 · 2011-12-29

ApplicantSiemens Medical Systems, Inc.
Decision Date2011-12-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM DEFINITION FLASH is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-12-29 under 510(k) number K113342. 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 SOMATOM DEFINITION FLASH?

SOMATOM DEFINITION FLASH is a medical device that received FDA 510(k) clearance on 2011-12-29. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K113342.

When did SOMATOM DEFINITION FLASH receive FDA 510(k) clearance?

SOMATOM DEFINITION FLASH received FDA 510(k) clearance on 2011-12-29, under 510(k) number K113342.

Who is the listed applicant for SOMATOM DEFINITION FLASH?

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

What is the FDA product code for SOMATOM DEFINITION FLASH?

The FDA product code for SOMATOM DEFINITION FLASH is JAK.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens Medical Systems, Inc. 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.

K123540SYNGO CT PULMO 3DK123541SYNGO.CT NEURO PERFUSIONK122909SYNGO SINGLE SOURCE DUAL ENGERYK122471SOMATOM DEFINITIONK120579SOMATOM DEFINITION EDGEK121072SOMATOM DEFINITION FLASH

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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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