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510(k) Data Aggregation
K Number
K171098Device Name
AXIS Image Management System
Manufacturer
Sonomed, Inc.
Date Cleared
2017-05-02
(19 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Sonomed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Storage, management, and display of patient data, diagnostic data, videos, and images from computerized ophthalmic diagnostic imaging devices.
Device Description
AXIS Image Management System is a browser-based ophthalmic image management system designed for storage, retrieval, and review of images, videos, and reports originating from ophthalmic imaging devices.
AXIS Image Management System and the predicate device are software systems that work on standard network infrastructure provided by the user. Such infrastructure may include a server, network, and computing devices.
AXIS Image Management System provides a central database of patient information and exam image history. The AXIS software resides on a server provided by the user and interfaces with networked imaging instruments. Users utilize their existing browser to access the AXIS software to review images, videos, and reports.
Images can be obtained from diagnostic devices in a variety of industry-standard formats including PDF, JPEG, DCM, and AVI.
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K Number
K140199Device Name
VUPAD
Manufacturer
SONOMED, INC.
Date Cleared
2014-04-01
(64 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
Device Description
The VuPad is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan). The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.
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K Number
K100252Device Name
MASTER-VU A-SCAN, MV4500
Manufacturer
SONOMED, INC.
Date Cleared
2010-04-09
(71 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Master-Vu A-Scan provides intraocular measurements of anterior chamber depth, lens thickness, and axial length which can be used with published industryaccepted refractive formulas to calculate associated IOL powers for implanted lenses.
Device Description
The Master-Vu A-Scan is a portable ultrasonic A-scan system intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses.
The Master-Vu A-Scan system consists of a solid A-probe, a base unit which houses the electronics, a foot pedal switch, and a USB cable which provides a means of interfacing the system with a host computer.
The standard Master-Vu software allows any Microsoft Windows compatible host computer (PC) to function as the control panel of the system. The host computer is not supplied by Sonomed as part of the Master-Vu A-Scan system and must be provided by the end user. Minimum requirements for compatible host computers are supplied in the documentation accompanying the system.
The Master-Vu software is compatible with the Microsoft Windows XP or Microsoft Windows Vista operating systems, and uses the features of the Windows graphical user interface to direct the operation of the system and maintain patient records. Patient data may be analyzed, saved, retrieved, and printed through the computer interface at the operator's discretion. The Microsoft Windows operating system provides an adequate and user-friendly interface for a wide variety of clinical environments.
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K Number
K092637Device Name
PACSCAN PLUS, MODELS 300P AND 300AP
Manufacturer
SONOMED, INC.
Date Cleared
2009-09-24
(28 days)
Product Code
ITX, IYO
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PacScan Plus is Sonomed's newest diagnostic ultrasound system which integrates a contact A-scan system, pachymeter, and analog thermal printer into a single unit for the convenient collection and retention of intraocular measurements. The system's principal application is to serve as an aid in the calculation of the associated IOL power for implanted lenses. As such, the PacScan Plus has been designed to capture key measurements such as axial length, anterior chamber depth and corneal thickness with both accuracy and precision.
Device Description
The PacScan™ Plus is the latest generation ophthalmic biometry instrument introduced by industry leading Sonomed. The series consists of two different models: PacScan™ 300A+. This A-scan system allows for measuring the axial length 0 (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. PacScan™ 300AP+. This system seamlessly integrates the A-Scan and 0 Pachymeter capabilities into a single system. All systems utilize a high-resolution, color backlit touch screen liquid crystal display (LCD) by which the user can enter information and view data and calculations. Each system also includes a built-in thermal printer. The system is compact and lightweight thereby making the system extremely portable.
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K Number
K073196Device Name
MASTER-VU
Manufacturer
SONOMED, INC.
Date Cleared
2007-12-19
(36 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan.
Device Description
The Master-Vu High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by B-scan. The system is PC-based, and is used with a 12 MHz transducer. The computer is a standard pc, and is user-supplied. Computer requirements are supplied in the instructions. The scanner is motor-driven. The system can also make measurements. The Master-Vu is a conventional ophthalmic B-scan system using a motor-driven transducer and angle sensor for scanning. It uses a motor-driven 12 MHz transducer. The system is PC-based, and the display is on the computer screen.
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K Number
K060626Device Name
VUMAX
Manufacturer
SONOMED, INC.
Date Cleared
2006-04-11
(33 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.
The VuMax ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultraseunded and to make measurements inside the eye.
The VuMax 35 MHz transducer is for use with the VuMax ultrasound system.
The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.
Device Description
The VuMax High Resolution Ultrasound System is intended to be used for visualization by ultrasound of the eye and orbit by A-scan and B-scan. It is not intended to be used for determining the nower of timabaned ocular lenses, but it is capable of making intra-ocular measurements.
The system is PC-based, and can be used with a 35 MHz transducer (standard) or a 50 MHz transducer (optional). Because of the higher frequency of the transducers, it is expected that its greatest field of application will be in visualizing the anterior segment, because the focus area is about 11 mm form the transducer plane. The system will visualize other parts of the eye, but the resolution is not as high.
The VuMax is a conventional ophthalmic A and B-scan system using a motor-driven transducer and angle sensor for scanning. The A-scan is derived from the B-scan. There is a choice of transducer frequency of 35 MHz or 50 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The system is PCbased, and the display is on the computer screen.
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K Number
K040668Device Name
E-Z SCAN AB5500+
Manufacturer
SONOMED, INC.
Date Cleared
2004-04-13
(29 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SONOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E-Z scan AB 5500+ ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power.
The Intended Use of the A_Mode probe for the E-Z scan AB 5500+ ultrasound system is to make measurements inside the eye, including the measurement of axial length for determination of IOL power, and to visualize the eye by means of A-scans.
The intended use of the B-Mode for the E-Z scan AB 5500 is to visualize the interior of the eye by means of ultrasound and to make measurements inside the eye by B-scan ultrasound.
Device Description
The E-Z Scan AB5500* combines a contact B-scanner used for the visualization by ultrasound of the eye and orbit and an A-scan used for intraocular measurements. The intended use of this system includes the localization and visualization of ophthalmic disorders and measurement of the eye and orbit.
The E-Z Scan AB5500+ is a conventional ophthalmic B-scan system using a motordriven transducer and angle sensor for scanning and a conventional contact A-scan system. The transducer frequency is 10 MHz. It uses a motor-driven 10 MHz transducer with an attached angle encoder. The display is on a video touch screen, also used for controlling the system. The entire device is computer-controlled by an internal microprocessor. The A-scan uses a separate 10 MIIz transducer and its own pulserreceiver.
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