FDA.reportPublic FDA data

VuMAX HD Ophthalmic Ultrasound System

Primary DI
00896100002224
Brand
VuMAX HD Ophthalmic Ultrasound System
Company
SONOMED, INC.
Model
VuMAX HD B/UBM
Catalog number
BU.575
Device description
"The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes.The B-scan modes ultilizes a sealed 12 MHz B-probe with a focused transducer and a water path probe with 35 MHz and/or 50 MHz transducer. Th system operates on a computer-based platform. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060626000VUMAXSonomed, Inc.2006-04-11IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896100002224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896100002224008961000022248961000022240896100002224

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.

Contacts#

Phone, Email table
PhoneEmail
800-227-1285info@sonomedinc.com

Regulatory Flags#

DUNS number
107037079
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896100002002AXIS Image Management SystemVer 5Axis2022-03-21
00896100002019VuPad Ophthalmic Ultrasound SystemVuPad APAP.5802020-12-07
00896100002026VuPad Ophthalmic Ultrasound SystemVuPad BPBP.5802020-12-07
00896100002033VuPad Ophthalmic Ultrasound SystemVuPad A/B/PBAP.5802020-12-07
00896100002040VuPad Ophthalmic Ultrasound SystemVuPad UBM/PUP.5802020-12-07
00896100002057VuPad Ophthalmic Ultrasound SystemVuPad B/UBM/PBUP.5802020-12-07
00896100002064VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBM/PBUAP.5802020-12-07
00896100002125VuPad Ophthalmic Ultrasound SystemVuPad BB.5802016-08-10
00896100002132VuPad Ophthalmic Ultrasound SystemVuPad A/BBA.5802016-08-10
00896100002149VuPad Ophthalmic Ultrasound SystemVuPad UBMU.5802016-08-10
00896100002156VuPad Ophthalmic Ultrasound SystemVuPad B/UBMBU.5802016-08-10
00896100002163VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBMBUA.5802016-08-10
00896100002170VuPad Ophthalmic Ultrasound SystemVuPad AA.5802016-08-10
00896100002088PacScan 300 Plus Ophthalmic Ultrasound300A+ A-Scan Only300A+2016-08-10
00896100002095PacScan 300 Plus Ophthalmic Ultrasound300AP+ A-Scan/Pachymeter300AP+2016-08-10
00896100002101Master-Vu A-Scan Ophthalmic Ultrasound SystemMV4500MV45002016-08-10
00896100002118Master-Vu B-Scan Ophthalmic Ultrasound SystemMV5600MV56002016-08-10
00896100002187VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD B ScanB.5752016-08-10
00896100002194VuMAX HD Ophthalmic Ultrasound SystemVuMAX-HD UBMU.5752016-08-10
00896100002200VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD A/BBA.5752016-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.IYO2026-08-07
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
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
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00195278713322RIC12-DGE Healthcare Austria GmbH & Co OGIYO2026-07-24
00841436122672Needle GuideCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
00198953078747LOGIQGE Medical Systems (China) Co.,Ltd.IYO2026-06-10
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
00198953113493LOGIQGE Ultrasound Korea Ltd.IYO2026-01-21
00841436126311Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00195278439352LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00195278439369LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05
00198953042731LOGIQGE Ultrasound Korea Ltd.IYO2025-12-05
00198953042748LOGIQGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCIYO2025-12-05