510(k) K191615
- Device
- Huvitz Imaging System
- Applicant
- Huvitz Co., Ltd.
- 510(k) number
- K191615
- Product code
- NFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-18
- Date received
- 2019-06-18
- Regulation
- 892.2050
- Classification name
- System, Image Management, Ophthalmic
- Medical specialty
- Radiology
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hyung Min Heo
- Address
- 38, Burim-Ro, 170beon-Gil, Dongan-Gu Anyang-Si, Dongan-Gu KR 14055 14055
FDA Registration Numbers#
- 3010197300
- 3011223751
- 3002807715
- 1000181430
- 9616199
- 2433682
- 2242863
- 9615010
- 9615030
- 2936921
- 3004026651
- 1000176188
- 8030392
- 3016735536
- 3014655548
- 3008422902
- 1316463
- 9614661
- 3012256561
- 3003995303
- 9617167
- 2918630
- 2183926
- 3038356864
- 3009422347
- 3009746052
- 3038614464
- 3008729548
- 3014606890
- 9680854
- 3011520729
- 3014926240
Source Documents#
Other 510(k) Records For Product Code NFJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026-06-04 |
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | 2024-08-22 |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-03-01 |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-12-21 |
| K232555 | Harmony | Topcon Healthcare Solutions | 2023-11-20 |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | 2023-08-28 |
| K232088 | Altris IMS | Altris, Inc. | 2023-07-31 |
| K220929 | Excelsior | Merit Cro, Inc. | 2022-10-31 |
| K213527 | FORUM | Carl Zeiss Meditec, AG | 2022-08-15 |
| K211715 | RetinAI Discovery | Retinai Medical AG | 2022-04-28 |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021-06-15 |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | 2020-12-24 |
| K201273 | ImageSPECTRUM | Canon, Inc. | 2020-09-25 |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | 2020-08-03 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases