FDA UDI
In Commercial Distribution
🇺🇸 United States
AMA Optics Digital Vision Test
DI: G506DG010
·
Model: DiagnosticGame
·
AMA Optics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMA Optics Digital Vision Test
- Primary DI
- G506DG010
- Version / Model
- DiagnosticGame
- Catalog Number
- DG01
- Company Name
- AMA Optics, Inc.
- Labeler DUNS
- 192827462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 16fbf74e-12d7-4f59-ab17-83805330f506
Device Description
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| QTO | Digital Visual Acuity Test | Ophthalmic | 886.1150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65889 | Vision testing software, patient-use | A software program intended to be used by a patient for self-testing of visual function under consultation of a clinician (e.g., ophthalmologist). It provides on-screen images (e.g., letters, shapes) whereby visual function can be tested over time (e.g., to monitor macular degeneration). It is intended to store and allow communication of the results with healthcare professionals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G506DG010 | HIBCC |