Panels › Ophthalmic › Product code OBO · Class 2
Tomography, Optical Coherence
Regulation 886.1570
3510(k)s in 12 months (67 all time)
1recalls in 12 months (12 all time)
10recalls that name a 510(k)
Top companies in OBO
| Company | 510(k)s | Recalls |
|---|---|---|
| Heidelberg Engineering | 20 | 3 |
| Carl Zeiss Meditec, AG | 12 | 5 |
| Optovue, Inc. | 7 | 3 |
| Topcon Corp. | 8 | 0 |
| Optos Plc. | 5 | 0 |
| Nidek Co., Ltd. | 3 | 0 |
| Tomey Corporation | 2 | 0 |
| Topcon Medical Systems, Inc. | 2 | 0 |
| Bioptigen, Inc. | 1 | 0 |
| C.S.O. S.R.L. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Heidelberg Engineering GmbH Brand Name: Heidelberg Engineering GmbH
Product Name: SPECTRALIS with Flex Module
Model/Catalog Number: S3610, S2610, S2000, S1610
multimodal imaging platform optimized for the posterior segment of t Open, Classified |
OBO | K181594 |
| Jan 14, 2022 | Carl Zeiss Meditec, Inc. CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Open, Classified |
OBO | K181534 |
| Nov 3, 2021 | Haag-Streit USA Inc OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4 Open, Classified |
OBO | K142953 |
| Jul 8, 2021 | Carl Zeiss Meditec, Inc. Chassis Label - "CIRRUS HD-OCT Rx-Only"
Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" Open, Classified |
OBO | K181534 |
| Jul 3, 2019 | Heidelberg Engineering GmbH SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device. Terminated |
OBO | K181594 |
| Oct 16, 2018 | Carl Zeiss Meditec, Inc. The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic i Terminated |
OBO | K161194 |
| Dec 8, 2017 | Heidelberg Engineering Widefield OCT software feature for the Spectralis HRA+OCT and variants Terminated |
OBO | None listed |
| Oct 9, 2012 | Optovue Inc. Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: Terminated |
OBO | K091404 K101505 |
| Mar 30, 2012 | Optovue Inc. RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) Terminated |
OBO | K111505 |
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0
The Cirrus HD-OCT is a non-contact, high resolution tomographic and bio Terminated |
OBO | K083291 |
| May 2, 2011 | Carl Zeiss Meditec Inc Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software.
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging Terminated |
OBO | K083291 |
| Mar 15, 2010 | Optovue Inc. Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA
The RTVue is an optical coherenc Terminated |
OBO | None listed |
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