FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AEYE Health
DI: 00850035651018
·
Model: AEYE-DS-Epic
·
Aeye Health, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AEYE Health
- Primary DI
- 00850035651018
- Version / Model
- AEYE-DS-Epic
- Company Name
- Aeye Health, Inc.
- Labeler DUNS
- 118503339
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-16
- Public Version
- 2
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- a0d14539-96fe-4144-804d-b14ff231370d
- Distribution End Date
- 2023-07-16
Device Description
AEYE-DS-Epic is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS-Epic is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR) and is integrated with the Epic EMR.
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
- No
- 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 |
|---|---|---|---|---|
| PIB | Diabetic Retinopathy Detection Device | Ophthalmic | 886.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58713 | Retinal image analysis software | A software program intended to analyse images of the retina to provide interpretive results for clinical decision support relating to retinal diseases (e.g., diabetic retinopathy, choroidal neovascularization). It utilizes specific algorithms and/or artificial intelligence (AI) and deep learning techniques to assess and perform interpretation of diagnostic images acquired by retinal imaging devices (e.g., fundus camera, retinal optical coherence tomography system, ophthalmoscope) for early diagnosis and management of patients at risk. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850035651018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221183 | 000 |