DEVICE: VuPad Ophthalmic Ultrasound System (00896100002026)
Device Identifier (DI) Information
VuPad Ophthalmic Ultrasound System
VuPad BP
In Commercial Distribution
BP.580
SONOMED, INC.
VuPad BP
In Commercial Distribution
BP.580
SONOMED, INC.
The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad BP is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers.
The system is provided with the portable B-Scan tablet, 12 MHz B-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11389 | Ophthalmic ultrasound imaging system |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IYO | System, Imaging, Pulsed Echo, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K140199 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
15961f94-d764-4fe8-8d89-98ba898e6df5
December 15, 2020
1
December 07, 2020
December 15, 2020
1
December 07, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-227-1285
info@sonomedinc.com
info@sonomedinc.com