FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
IMAGEnet6 Ophthalmic Data System
K Number: K232828
·
Decision Mar 1, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
13
Review Days
170
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Basic Information
- Device Name
- IMAGEnet6 Ophthalmic Data System
- K Number
- K232828
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Corporation
- Date Received
- September 13, 2023
- Decision Date
- March 1, 2024
- Product Code
- NFJ
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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Other Clearances by Topcon Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Nov 7, 2025 | Substantially Equivalent |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Jul 17, 2024 | Substantially Equivalent |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Apr 10, 2024 | Substantially Equivalent |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Oct 30, 2023 | Substantially Equivalent |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Aug 29, 2022 | Substantially Equivalent |
| K173119 | DRI OCT Triton | Jan 19, 2018 | Substantially Equivalent |
| K171370 | IMAGEnet 6 Ophthalmic Data System | Nov 1, 2017 | Substantially Equivalent |
| K170164 | 3D OCT-1 Maestro | Mar 3, 2017 | Substantially Equivalent |
| K161972 | Slit Lamp SL-D301 | Dec 9, 2016 | Substantially Equivalent |
| K161509 | 3D OCT-1 Maestro | Jul 28, 2016 | Substantially Equivalent |