NFJ · System, Image Management, Ophthalmic
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | NFJ |
|---|---|
| Device Name | System, Image Management, Ophthalmic |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Recent Cleared Devices (20 of 51)
Showing 20 most recent of 51 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234076 | iCare ALTIUS CW | Centervue S.P.A. | Aug 22, 2024 | SESE |
| K232828 | IMAGEnet6 Ophthalmic Data System | Topcon Corporation | Mar 1, 2024 | SESE |
| K232944 | CALLISTO eye | Carl Zeiss Meditec, AG | Dec 21, 2023 | SESE |
| K232555 | Harmony | Topcon Healthcare Solutions | Nov 20, 2023 | SESE |
| K231676 | CALLISTO eye | Carl Zeiss Meditec, AG | Aug 28, 2023 | SESE |
| K232088 | Altris IMS | Altris, Inc. | Jul 31, 2023 | SESE |
| K220929 | Excelsior | Merit Cro, Inc. | Oct 31, 2022 | SESE |
| K213527 | FORUM | Carl Zeiss Meditec, AG | Aug 15, 2022 | SESE |
| K211715 | RetinAI Discovery | Retinai Medical AG | Apr 28, 2022 | SESE |
| K210396 | Harmony Referral System | Topcon Healthcare Solutions EMEA Oy | Sep 13, 2021 | SESE |
| K203244 | CellChek 20 rc | Konan Medical, Inc. | Jun 15, 2021 | SESE |
| K200422 | Image Quality Analyzer (IQA) | Visionquest Biomedical, Inc. | Dec 24, 2020 | SESE |
| K201273 | ImageSPECTRUM | Canon, Inc. | Sep 25, 2020 | SESE |
| K200954 | Glaucoma Module | Topcon Healthcare Solutions, Inc. | Aug 3, 2020 | SESE |
| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | Mar 16, 2020 | SESE |
| K200275 | OVision Imaging System | Ophthalmic Labs, Inc. | Mar 3, 2020 | SESE |
| K191615 | Huvitz Imaging System | Huvitz Co., Ltd. | Jul 18, 2019 | SESE |
| K190056 | KOWA VK-2s | Kowa Co. Ltd. Chofu | Feb 12, 2019 | SESE |
| K181501 | Afina | Neurovision Imaging, LLC | Nov 2, 2018 | SESE |
| K182318 | Retina Workplace | Carl Zeiss Meditec, Inc. | Oct 24, 2018 | SESE |
Top Applicants
- Carl Zeiss Meditec, AG — 10 clearances
- Topcon Medical Systems, Inc. — 5 clearances
- Topcon Corporation — 2 clearances
- Optos Plc. — 2 clearances
- Konan Medical, Inc. — 2 clearances
