VuPad Ophthalmic Ultrasound System
Basic Information
- Brand Name
- VuPad Ophthalmic Ultrasound System
- Primary DI
- 00896100002057
- Version / Model
- VuPad B/UBM/P
- Catalog Number
- BUP.580
- Company Name
- SONOMED, INC.
- Labeler DUNS
- 107037079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-07
- Public Version
- 1
- Public Version Date
- 2020-12-15
- Public Version Status
- New
- Public Device Record Key
- 7eda6102-8038-46aa-89b6-fc3e362e953a
Device Description
The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan, UBM (high frequency B-scan), and pachymetry. 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 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/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe, power supply, foot switch and user manual.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896100002057 | GS1 |
Customer Contacts
- Phone
- 800-227-1285
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140199 | 000 |