FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDx-DR v2.3
K Number: K213037
·
Decision Jun 17, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
2
Review Days
269
Basic Information
- Device Name
- IDx-DR v2.3
- K Number
- K213037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digital Diagnostics Inc.
- Date Received
- September 21, 2021
- Decision Date
- June 17, 2022
- Product Code
- PIB
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PIB | Diabetic Retinopathy Detection Device | FDA class 2 | Ophthalmic |
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Other Clearances by Digital Diagnostics Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203629 | IDx-DR | Jun 10, 2021 | Substantially Equivalent |