FDA.reportPublic FDA data

VuMAX HD Ophthalmic Ultrasound System

Primary DI
00896100002248
Brand
VuMAX HD Ophthalmic Ultrasound System
Company
SONOMED, INC.
Model
VuMAX HD A/UBM
Catalog number
AU.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 A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. The system operates on a computer-based platform. 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, 10 MHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
Published
2017-03-27
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
00896100002248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896100002248008961000022488961000022480896100002248

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

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