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FDA 510(k)

SNN FLUORO NAVIGATION SYSTEM

K-Number: K993673 · 1999-12-21

ApplicantI.S.G. Technologies, Inc.
Decision Date1999-12-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SNN FLUORO NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I.S.G. Technologies, Inc.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K993673. 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 SNN FLUORO NAVIGATION SYSTEM?

SNN FLUORO NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is I.S.G. Technologies, Inc.. The 510(k) number is K993673.

When did SNN FLUORO NAVIGATION SYSTEM receive FDA 510(k) clearance?

SNN FLUORO NAVIGATION SYSTEM received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993673.

Who is the listed applicant for SNN FLUORO NAVIGATION SYSTEM?

The FDA 510(k) record lists I.S.G. Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNN FLUORO NAVIGATION SYSTEM?

The FDA product code for SNN FLUORO NAVIGATION SYSTEM is HAW.

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Other records listing I.S.G. Technologies, 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.

K982570SNN SCOUTK980684VR NETSERVEK973413ID. STORE (RELEASE 2.0)K970865ISG FAMILY OF VIEWING WANDSK960714ISG VIEWING WANDK941933ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)

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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

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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