FDA.reportPublic FDA data

Dolphin/XF Robot Accessory

Primary DI
07290016880229
Brand
Dolphin/XF Robot Accessory
Company
VIASONIX LTD
Model
Dolphin/XF Robot Accessory
Device description
The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity
Published
2021-03-31
Public version status
New
Distribution status
Not 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
OQQDiagnostic Ultrasonic Transducer, Robotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
OQQDiagnostic Ultrasonic Transducer, RoboticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202742000Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix , Ltd.2021-01-25IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016880229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016880229072900168802297290016880229

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533070236
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
072900168803974 MHz probe 4 MHz probePVC03302022-08-08
072900168804038 MHz probe 8 MHz probePVC03312022-08-08
07290016880540DolphinXpress2025-11-20
0729001688041010 MHz probe 10 MHz probePVC03322022-08-08
07290016880441Detachable PPG Clip sensorDetachable PPG Clip sensor2024-12-27
07290016880533Falcon/XpressFalcon/Xpress2024-12-27
07290016880489Pressure Cuff Size 12LPressure Cuff Size 12L2023-06-29
07290016880496Pressure Cuff Size 2.5Pressure Cuff Size 2.52023-06-29
07290016880502Pressure Cuff Size 1.9Pressure Cuff Size 1.92023-06-29
07290016880519Pressure Cuff Size 1.6Pressure Cuff Size 1.62023-06-29
07290016880526Pressure Cuff Size 7Pressure Cuff Size 72023-06-29
07290016880465Pressure Cuff Size 10Pressure Cuff Size 102023-06-23
07290016880472Pressure Cuff Size 12Pressure Cuff Size 122023-06-25
0729001688007610 MHz probe 10 MHz probe2020-06-19
07290016880168Toe Clip PPG Sensor Toe Clip PPG Sensor PVC01432020-06-19
07290016880175Disk PPG sensor Disk PPG sensor 2020-06-19
07290016880182Fingerclip PPG sensor Fingerclip PPG sensor 2020-06-19
07290016880250LiteWalkLiteWalk2020-06-19
07290016880267LiteWalk SandalsLargePVC0268-L2020-06-19
07290016880274LiteWalk SandalsMediumPVC0268-M2020-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYN2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYN2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953126073VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYN2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYN2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25