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FDA 510(k)

Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI

K-Number: K984298 · 1999-06-23

ApplicantZ-Kat, Inc.
Decision Date1999-06-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI is the device name listed in this FDA 510(k) record. The listed applicant is Z-Kat, Inc.. It received FDA 510(k) clearance on 1999-06-23 under 510(k) number K984298. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI?

Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI is a medical device that received FDA 510(k) clearance on 1999-06-23. The listed applicant is Z-Kat, Inc.. The 510(k) number is K984298.

When did Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI receive FDA 510(k) clearance?

Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI received FDA 510(k) clearance on 1999-06-23, under 510(k) number K984298.

Who is the listed applicant for Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI?

The FDA 510(k) record lists Z-Kat, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI?

The FDA product code for Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI is HAW.

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 Z-Kat, 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.

K030764Z-BOXK023975VOYAGER LINUXK013025MODIFICATION TO FLOUROLAB PLUSK002893FLUOROLAB PLUS

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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