FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions

SubmissionSupplement
K250524000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250524000Mendaera Guidance SystemMendaera, Inc.2025-07-02ITX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850062065000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062065000008500620650008500620650000850062065000

GMDN Terms

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

TypeValueUnit
Weight75Kilogram

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-877-636-3237support@mendaera.com

Regulatory Flags

DUNS number
100193165
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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

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