Company ยท US
Topcon Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2018. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 2018 | K182376 | Harmony Topcon Medical Systems, Inc. | NFJ |
| Oct 1, 2015 | K151952 | Synergy ODM Topcon Medical Systems, Inc. | NFJ |
| Oct 17, 2013 | K132438 | IMAGENET 5 PC SOFTWARE SYSTEM Topcon Medical Systems, Inc. | NFJ |
| Oct 9, 2013 | K132667 | SYNERGY ODM Topcon Medical Systems, Inc. | NFJ |
| Jun 5, 2013 | K123101 | TRC-50DX RETINAL CAMERA Topcon Medical Systems, Inc. | HKI |
| Feb 6, 2013 | K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA Topcon Medical Systems, Inc. | HKI |
| May 23, 2011 | K110489 | SLIT LAMP SL-2G Topcon Medical Systems, Inc. | HJO |
| Dec 2, 2009 | K093313 | SYNERGY Topcon Medical Systems, Inc. | NFJ |
| Mar 13, 2009 | K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM Topcon Medical Systems, Inc. | OBO |
| Jan 13, 2009 | K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS Topcon Medical Systems, Inc. | OBO |
| Dec 19, 2003 | K031831 | TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM Topcon Medical Systems, Inc. | HKO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2024 | Topcon Medical Systems, Inc. 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 Open, Classified |
NFJ | K232828 |
| Dec 18, 2020 | Topcon Medical Systems, Inc. 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 a Terminated |
NFJ | None listed |
| Apr 12, 2019 | Topcon Medical Systems, Inc. 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 clini Terminated |
NFJ | K171370 |