Product code OBO
- Device name
- Tomography, Optical Coherence
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1570
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026-05-07 |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2025-05-12 |
| K240924 | Anterion | Heidelberg Engineering GmbH | 2024-12-13 |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2024-10-11 |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-07-17 |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024-07-01 |
| K233933 | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| K233602 | P200TE (A10700) | Optos Plc. | 2024-05-09 |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024-04-10 |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | 2024-03-08 |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023-10-30 |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023-10-20 |
| K230897 | Anterion | Heidelberg Engineering GmbH | 2023-10-11 |
| K221601 | MS-39 | C.S.O. S.R.L. | 2023-09-01 |
| K231673 | P200TE (A10700) | Optos Plc. | 2023-08-18 |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | Nidek Co., Ltd. | 2023-03-30 |
| K222166 | SOLIX | Optovue, Inc. | 2022-11-09 |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022-04-27 |
| K211817 | Anterion | Heidelberg Engineering GmbH | 2021-11-05 |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020-09-09 |
| K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | 2020-09-02 |
| K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019-09-26 |
| K190732 | P200TxE | Optos Plc. | 2019-07-31 |
| K182942 | Canon OCT-A1 | Canon, Inc. | 2019-07-24 |
| K181534 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2019-02-15 |
| K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019-01-11 |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04049584034953 | Pentacam Cornea OCT | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2026-03-31 |
| 03615020000496 | ANAEYES OCT for system linkage | ESSILOR INTERNATIONAL | 2021-02-18 |
| 00857691006374 | ENFOCUS 2300 INTEGRATED OCT | BIOPTIGEN, INC. | 2020-11-19 |
| 00858848006766 | iFusion | OPTOVUE, INC. | 2020-08-24 |
| 00857691006367 | ENVISU C2300 VHR 100V | BIOPTIGEN, INC. | 2020-06-01 |
| 00858848006728 | RTVue XR Avanti | OPTOVUE, INC. | 2020-02-03 |
| 04059237000464 | SPECTRALIS | Heidelberg Engineering GmbH | 2020-01-21 |
| 04059237000488 | SPECTRALIS | Heidelberg Engineering GmbH | 2020-01-21 |
| 00850003069142 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-08-05 |
| 00858848006667 | RTVue XR Avanti Scanner | OPTOVUE, INC. | 2019-06-12 |
| 00858848006674 | RTVue XR Avanti | OPTOVUE, INC. | 2019-06-12 |
| 00850003069050 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-14 |
| 00850003069005 | IMAGEnet 6 | TOPCON HEALTHCARE SOLUTIONS, INC. | 2019-02-12 |
| 00858848006650 | iFusion | OPTOVUE, INC. | 2019-01-21 |
| 00858848006643 | iFusion | OPTOVUE, INC. | 2019-01-21 |
| 00858848006636 | iFusion | OPTOVUE, INC. | 2019-01-21 |
| 00858848006629 | iFusion | OPTOVUE, INC. | 2019-01-21 |
| 04059237000525 | SPECTRALIS | Heidelberg Engineering GmbH | 2019-01-03 |
| 00858848006452 | RTVue XR Avanti | OPTOVUE, INC. | 2018-09-06 |
| 04059237000396 | SPECTRALIS, HEP | Heidelberg Engineering GmbH | 2018-07-11 |
| 04059237000303 | SPECTRALIS | Heidelberg Engineering GmbH | 2017-06-12 |
| 04059237000242 | SPECTRALIS, HRT3, HEP | Heidelberg Engineering GmbH | 2016-12-16 |
| 04059237000044 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000068 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000075 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000082 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000136 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000259 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04059237000037 | SPECTRALIS | Heidelberg Engineering GmbH | 2016-09-24 |
| 04049471070118 | Retina Workplace | Carl Zeiss Meditec AG | 2016-09-16 |