FDA.reportPublic FDA data

FOCALYX TECHNOLOGIES

Matched from indexed company URL: Focalyx Technologies, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165674003016567400FOCALYX TECHNOLOGIES1N2026-01-012140 W 68th St Ste 406 Hialeah FL US 33016

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860003552001Focalyx Fusion - The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to aid targeted needle guidance in the diagnosis or treatment of prostate disease. The system is to be used by qualified physicians who are familiar with the safe operation of transrectal ultrasound and positioning devices during medical procedures involving the prostate. There are no known contraindications for the use of the device.1-888-636-2259support@focalyxtechnologies.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2390681893389609K170250SmartTargetLLZ2017-06-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12017-06-07

GUDID#

Focalyx Fusion - The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to aid targeted needle guidance in the diagnosis or treatment of prostate disease. The system is to be used by qualified physicians who are familiar with the safe operation of transrectal ultrasound and positioning devices during medical procedures involving the prostate. There are no known contraindications for the use of the device.

Focalyx Technologies, LLC

2026-01-02