Duns Number:107037079
Device Description: The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and bio The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes A-Scan, B-Scan and pachymeter capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad 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. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. 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 tablet, 12 MHz B-probe, 10 MHz A-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
Catalog Number
BAP.580
Brand Name
VuPad Ophthalmic Ultrasound System
Version/Model Number
VuPad A/B/P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140199
Product Code
IYO
Product Code Name
System, Imaging, Pulsed Echo, Ultrasonic
Public Device Record Key
7ba83960-cc9b-425a-9ce1-837220d07ac1
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |