FDA.report

Focalist System Software

Primary DI
00850062065031
Brand
Focalist System Software
Company
Mendaera, Inc.
Model
rc25
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850062065031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062065031008500620650318500620650310850062065031

GMDN Terms

TermDefinition
Ultrasound imaging system operation softwareMainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a diagnostic ultrasound system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used identify different operating system versions.

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
true
Serial number
false
Manufacturing date on label
false
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
00850062065000Focalist SystemC001-012025-08-11
10850062065021Mendaera Universal Instrument Guide Kit, LongK001-012025-08-11
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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