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FDA 510(k)

CT-GUIDE NEEDLE GUIDANCE SYSTEM

K-Number: K113063 · 2011-11-10

ApplicantActiviews, Ltd.
Decision Date2011-11-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT-GUIDE NEEDLE GUIDANCE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Activiews, Ltd.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K113063. 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 CT-GUIDE NEEDLE GUIDANCE SYSTEM?

CT-GUIDE NEEDLE GUIDANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Activiews, Ltd.. The 510(k) number is K113063.

When did CT-GUIDE NEEDLE GUIDANCE SYSTEM receive FDA 510(k) clearance?

CT-GUIDE NEEDLE GUIDANCE SYSTEM received FDA 510(k) clearance on 2011-11-10, under 510(k) number K113063.

Who is the listed applicant for CT-GUIDE NEEDLE GUIDANCE SYSTEM?

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

What is the FDA product code for CT-GUIDE NEEDLE GUIDANCE SYSTEM?

The FDA product code for CT-GUIDE NEEDLE GUIDANCE SYSTEM 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.

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Other records listing Activiews, Ltd. 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.

K120300CT-GUIDE NEEDLE GUIDANCE SYSTEMK110812CT-GUIDE NEEDLE GUIDANCE SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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