FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Image Filing Software NAVIS-EX
K Number: K181345
·
Decision Jul 19, 2018
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
20
Review Days
59
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Basic Information
- Device Name
- Image Filing Software NAVIS-EX
- K Number
- K181345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek Co., Ltd.
- Date Received
- May 21, 2018
- Decision Date
- July 19, 2018
- 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 Nidek Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | Mar 30, 2023 | Substantially Equivalent |
| K203130 | Ophthalmic Yag Laser System YC-200 | Dec 7, 2020 | Substantially Equivalent |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nov 15, 2019 | Substantially Equivalent |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Apr 1, 2019 | Substantially Equivalent |
| K173980 | Specular Microscope CEM-530 | Mar 14, 2018 | Substantially Equivalent |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Jun 23, 2017 | Substantially Equivalent |
| K163564 | SLIT LAMP SL-2000 | May 19, 2017 | Substantially Equivalent |
| K152729 | MICROPERIMETER MP-3 | Jun 6, 2016 | Substantially Equivalent |
| K152603 | Green Laser Photocoagulator GYC-500 | May 2, 2016 | Substantially Equivalent |
| K151706 | Specular Microscope CEM- 530 | Mar 17, 2016 | Substantially Equivalent |