FDA.reportPublic FDA data

Transducer X11-4t

Primary DI
00884838102729
Brand
Transducer X11-4t
Company
Philips Ultrasound LLC
Model
989605501821
Published
2024-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OBJCatheter, Ultrasound, Intravascular
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233545000EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2023-11-30IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838102729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838102729008848381027298848381027290884838102729

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal ultrasound imaging transducer, reusableAn ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063377717
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838130425Transducer V9-23000162230612026-04-14
00884838130432Transducer MC12-33000162230912026-04-14
00884838130449Transducer ML26-83000162231212026-04-14
00884838112988Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838124929Affiniti 30 Diagnostic Ultrasound System7951802026-01-08
00884838127098Affiniti 50 Diagnostic Ultrasound System7951182026-01-08
00884838127111EPIQ 5 Diagnostic Ultrasound System7951202026-01-08
00884838127128EPIQ Elite Diagnostic Ultrasound System7951252026-01-08
00884838126305EPIQ Diagnostic Ultrasound System7954182025-10-17
00884838126893EPIQ Diagnostic Ultrasound System7951222025-06-23
00884838126930EPIQ Diagnostic Ultrasound System7952322025-06-23
00884838124912EPIQ Elite Diagnostic Ultrasound System7952342024-12-19
00884838124974Affiniti 30 Diagnostic Ultrasound System7952182024-12-19
00884838124981Affiniti 50 Diagnostic Ultrasound System7952082024-12-19
00884838124998Affiniti 70 Diagnostic Ultrasound System7952102024-12-19
00884838125674Affiniti CVx Diagnostic Ultrasound System Circular Edition7954072024-06-12
00884838125643EPIQ CVx Diagnostic Ultrasound System7951222024-06-03
00884838125650EPIQ Series Diagnostic Ultrasound System7951172024-06-03
00884838123960EPIQ Diagnostic Ultrasound System7952312024-05-29
00884838123977EPIQ Diagnostic Ultrasound System7952322024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYN2026-08-07
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
00845225013011ICE PIMPhilips Image Guided Therapy CorporationOBJ2026-07-30
10801902219333ARROWTELEFLEX INCORPORATEDOBJ2026-07-30
10801902194654ARROWTELEFLEX INCORPORATEDOBJ2026-07-29
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436127028Verza Guidance SystemCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436127035Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125311CIV-Clear™ Transducer CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125915Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125939Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436125953Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127056Cable SleeveCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
10841436127186Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGITX2026-07-24