FDA.reportPublic FDA data

Focalist System

Primary DI
00850062065000
Brand
Focalist System
Company
Mendaera, Inc.
Model
C001-01
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250524000Mendaera Guidance SystemMendaera, Inc.2025-07-02ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062065000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062065000008500620650008500620650000850062065000

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system operator consoleA device that is a component of a diagnostic ultrasound imaging system that functions as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced into a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the ultrasound system and is typically incorporated in the system design as is the case with mobile or portable ultrasound systems.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight75Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-636-3237support@mendaera.com

Regulatory Flags#

DUNS number
100193165
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062065055Focalist Universal Short Instrument Guide KitK002-012026-04-29
00850062065079Focalist Universal Long Instrument Guide KitK001-012026-04-29
00850062065093Focalist Robot Drape KitK003-012026-04-29
00850062065109Focalist Probe and Robot Drape KitK004-012026-04-29
00850062065116Focalist System Software12026-04-29
00850062065024Mendaera Universal Instrument Guide Kit, LongK001-012025-08-11
00850062065048Mendaera Universal Instrument Guide Kit, ShortK002-012025-08-11
00850062065062Mendaera Robot Drape KitK003-012025-08-11
10850062065021Mendaera Universal Instrument Guide Kit, LongK001-012025-08-11
00850062065031Focalist System Softwarerc252025-08-11
10850062065045Mendaera Universal Instrument Guide Kit, ShortK002-012025-08-11
10850062065069Mendaera Robot Drape KitK003-012025-08-11
00850062065086Mendaera Probe and Robot Drape KitK004-012025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
08056304455628MyLabE80ESAOTE SPAITX2024-03-29