Data / Medical devices / United States / Topcon Healthcare, Inc.
Topcon Healthcare, Inc.: FDA-registered device maker in Oakland, NJ, United States, 4 510(k) clearances
Topcon Healthcare, Inc. is registered with the FDA (registration 2242863) in Oakland, NJ, United States. It lists 16 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 20, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2242863
- Address
- 111 Bauer Dr, Oakland, NJ, United States, 07436
- Owner or operator
- Topcon Healthcare, Inc. (2242863)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 13, 1994
- Registered through
- 2026
- Brand names listed
- AIT-250W; AIT-350W; AIT-650; IDS-300; AIT-W1; AIT-W2, CLOUD, EZ Lite 2, Harmony, IS-5000; CS-5; IS-5500, IS-6500, OC-2200, OC-2300; OC-2400 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2023 | K232555 | Harmony | NFJ | Substantially Equivalent | Topcon Healthcare Solutions | accessdata.fda.gov |
| September 28, 2018 | K182376 | Harmony | NFJ | Substantially Equivalent | Topcon Medical Systems, Inc. | accessdata.fda.gov |
| November 1, 2017 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | Substantially Equivalent | Topcon Corporation | accessdata.fda.gov |
| October 1, 2015 | K151952 | Synergy ODM | NFJ | Substantially Equivalent | Topcon Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2024 | 95485 | Class II | Ongoing | The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices | The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided | accessdata.fda.gov |
| December 18, 2020 | 87086 | Class II | Terminated | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient informati | Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient records and images to be combined under the first generated record | accessdata.fda.gov |
| March 6, 2019 | 82322 | Class II | Terminated | IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from | When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used. | accessdata.fda.gov |
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Updated November 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.