FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K Number: K101935
·
Decision Oct 27, 2010
Classifications
1
FEI Numbers
67
Registration Numbers
68
Same Product Code
151
Applicant Total
7
Review Days
107
Basic Information
- Device Name
- CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
- K Number
- K101935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CENTERVUE SPA
- Date Received
- July 12, 2010
- Decision Date
- October 27, 2010
- Product Code
- HKI
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by CENTERVUE SPA
| K Number | Device Name | ||
|---|---|---|---|
| K243504 | MAIA (AHMACME001) | Mar 17, 2025 | Substantially Equivalent |
| K153181 | MAIA | Jun 8, 2016 | Substantially Equivalent |
| K150320 | COMPASS | Jun 30, 2015 | Substantially Equivalent |
| K142047 | EIDON | Nov 12, 2014 | Substantially Equivalent |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Apr 23, 2014 | Substantially Equivalent |
| K092187 | MAIA, MODEL 1 | May 27, 2010 | Substantially Equivalent |