PanoCam™ PRO
Basic Information
- Brand Name
- PanoCam™ PRO
- Primary DI
- 00850938007011
- Version / Model
- PNPR-11-10-11
- Company Name
- VISUNEX MEDICAL SYSTEMS INC.
- Labeler DUNS
- 080033068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-10-09
- Public Version Status
- Update
- Public Device Record Key
- 32df7acc-69c3-4e65-98b8-07019150293f
Device Description
PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| PJZ | Camera, Ophthalmic, General-Use | Ophthalmic | 886.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61569 | External ocular measurement camera | A hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850938007011 | GS1 |
Customer Contacts
- Phone
- 1-844-273-1580
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal