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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K261019 | ANTERION Heidelberg Engineering GmbH, DE | OBO |
| May 7, 2026 | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module Heidelberg Engineering GmbH, DE | OBO |
| Dec 23, 2025 | K252633 | UNITY DX (UDX) Cylite Pty. , Ltd., AU | OBO |
| Jul 18, 2025 | K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) Tomey Corporation, JP | OBO |
| May 12, 2025 | K250868 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Dec 13, 2024 | K240924 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Oct 11, 2024 | K241163 | SPECTRALIS with Flex Module Heidelberg Engineering GmbH, DE | OBO |
| Jul 17, 2024 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System Topcon Corporation, JP | OBO |
| Jul 1, 2024 | K240221 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| May 17, 2024 | K233933 | CIRRUS HD-OCT Model 6000 Carl Zeiss Meditec, Inc. | OBO |
| May 9, 2024 | K233602 | P200TE (A10700) Optos Plc., GB | OBO |
| Apr 10, 2024 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) Topcon Corporation, JP | OBO |
| Mar 8, 2024 | K233421 | RESCAN 700 Carl Zeiss Meditec, AG, DE | OBO |
| Oct 30, 2023 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) Topcon Corporation, JP | OBO |
| Oct 20, 2023 | K223557 | SPECTRALIS HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Oct 11, 2023 | K230897 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Sep 1, 2023 | K221601 | MS-39 C.S.O. S.R.L., IT | OBO |
| Aug 18, 2023 | K231673 | P200TE (A10700) Optos Plc., GB | OBO |
| Apr 13, 2023 | K222200 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Mar 30, 2023 | K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Nidek Co., Ltd., JP | OBO |
| Nov 9, 2022 | K222166 | SOLIX Optovue, Inc. | OBO |
| Apr 27, 2022 | K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 Tomey Corporation, JP | OBO |
| Nov 5, 2021 | K211817 | Anterion Heidelberg Engineering GmbH, DE | OBO |
| Sep 9, 2020 | K201252 | Spectralis HRA+OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Sep 2, 2020 | K200516 | OCT-Camera ID 21101A3 Optomedical Technologies GmbH, DE | OBO |
| Sep 26, 2019 | K192391 | Spectralis HRA+OCT and Variants Heidelberg Engineering GmbH, DE | OBO |
| Jul 31, 2019 | K190732 | P200TxE Optos Plc., GB | OBO |
| Jul 24, 2019 | K182942 | Canon OCT-A1 Canon, Inc., JP | OBO |
| Feb 15, 2019 | K181534 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Jan 11, 2019 | K180229 | RESCAN 700, CALLISTO eye Carl Zeiss Meditec, AG, DE | OBO |
| Oct 18, 2018 | K182569 | Spectralis HRA+OCT and variants with High Magnification Module Heidelberg Engineering GmbH, DE | OBO |
| Sep 13, 2018 | K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module Heidelberg Engineering GmbH, DE | OBO |
| Aug 30, 2018 | K173648 | Spectralis HRA + OCT and variants Heidelberg Engineering GmbH, DE | OBO |
| Jun 8, 2018 | K180660 | Avanti Optovue, Inc. | OBO |
| Feb 28, 2018 | K173707 | P200TE Optos Plc., GB | OBO |
| Jan 19, 2018 | K173119 | DRI OCT Triton Topcon Corporation, JP | OBO |
| Nov 1, 2017 | K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Heidelberg Engineering GmbH, DE | OBO |
| Jun 21, 2017 | K163195 | PRIMUS Carl Zeiss Suzhou Co., Ltd., CN | OBO |
| Jun 9, 2017 | K163475 | iVue Optovue, Inc. | OBO |
| Mar 3, 2017 | K170164 | 3D OCT-1 Maestro Topcon Corporation, JP | OBO |
| Dec 9, 2016 | K162783 | EnFocus 2300, EnFocus 4400 Bioptigen, Inc. | OBO |
| Oct 26, 2016 | K161194 | PLEX Elite 9000 SS-OCT Carl Zeiss Meditec, Inc. | OBO |
| Jul 28, 2016 | K161509 | 3D OCT-1 Maestro Topcon Corporation, JP | OBO |
| May 6, 2016 | K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spect Heidelberg Engineering GmbH, DE | OBO |
| Sep 1, 2015 | K150977 | CIRRUS HD-OCT Carl Zeiss Meditec, Inc. | OBO |
| Nov 18, 2014 | K141844 | RESCAN 700, CALLISTO EYE Carl Zeiss Meditec, AG | OBO |
| Mar 19, 2014 | K133217 | CIRRUS PHOTO Carl Zeiss Meditec, AG | OBO |
| Feb 19, 2014 | K132323 | RS-3000 ADVANCE Nidek Co., Ltd. | OBO |
| Mar 14, 2013 | K121622 | NIDEK RS-3000 Nidek Co., Ltd. | OBO |
| Feb 22, 2013 | K121043 | OPTOS OCT/SLO MICROPERIMETER Optos Plc. | OBO |
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