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FDA 510(k)

GammaTile

K-Number: K190296 · 2019-03-13

ApplicantGt Medical Technologies
Decision Date2019-03-13
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GammaTile is the device name listed in this FDA 510(k) record. The listed applicant is Gt Medical Technologies. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K190296. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GammaTile?

GammaTile is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Gt Medical Technologies. The 510(k) number is K190296.

When did GammaTile receive FDA 510(k) clearance?

GammaTile received FDA 510(k) clearance on 2019-03-13, under 510(k) number K190296.

Who is the listed applicant for GammaTile?

The FDA 510(k) record lists Gt Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GammaTile?

The FDA product code for GammaTile is KXK.

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.

NCT04427384Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)RECRUITINGNCT07195591Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of CareRECRUITING

Other records listing Gt Medical Technologies 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.

K221539GammaTileK190839GammaTile

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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