Identity
- Trade Name
- iScreen Vision FDA UDI
- Generic Name
- External ocular measurement camera FDA UDI
- Device Name
- The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals. FDA UDI
- Model / Reference
- iScreen Vision Screener 3000 FDA UDI
- Description
- The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00864218000104 FDA UDI
- 510(k) Number
- K102651 FDA UDI
- FDA Product Code
- HKI FDA UDI
- GMDN Term
- External ocular measurement camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External ocular measurement camera
iScreen Vision by Iscreen Vision Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Iscreen Vision Inc.
Sources (1)
- FDA UDI 578c673b-8a53-4f09-9f11-06f794ee6dbf 35 fields · synced May 30, 2026