Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014663932

FEI Number

3014663932

Entity Name

GT MEDICAL TECHNOLOGIES, INC

City/State/Country

Tempe, AZ, US

Establishment Address

1809 S Holbrook Ln, STE 107, Tempe, AZ 85281, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GT Medical Technologies, Inc (Owner Number: 10058091)

Owner / Operator Contact Address

1809 S Holbrook Ln., Tempe, AZ,, STE 107, Tempe, AZ 85281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221539

PMA Number

N/A

All Registered Proprietary Names

GammaTile GammaTile GammaTile Radiation Shielding Tray GammaTile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2022-12-15
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2022-12-15
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2019-12-11
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2018-07-07
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2022-12-15

Official Correspondent

Jessica Newhard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GT Medical Technologies, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005520039	GT Medical Technologies	RICHLAND, WA, US
3017496466	GT Medical Technologies	Richland, WA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014663932. Last updated year: 2026. Please use registration number 3014663932 when referencing this establishment in official correspondence.