Tomography, Optical Coherence
FDA product code OBO · 63 cleared devices
Class 2
Ophthalmic
- Regulation
- 21 CFR 886.1570
- Review panel
- OP
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2006-10-06 – 2026-09-11
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
OBO
2026-09-11
OBO
2026-05-07
SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
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OBO
2025-12-23
UNITY DX (UDX)
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OBO
2025-07-18
Tomey Cornea/Anterior Segment OCT (CASIA2)
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OBO
2025-05-12
SPECTRALIS HRA+OCT and variants
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OBO
2024-12-13
Anterion
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OBO
2024-10-11
SPECTRALIS with Flex Module
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OBO
2024-07-17
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
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OBO
2024-07-01
SPECTRALIS HRA+OCT and variants
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OBO
2024-05-17
CIRRUS™ HD-OCT Model 6000
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OBO
2024-05-09
P200TE (A10700)
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OBO
2024-04-10
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
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OBO
2024-03-08
RESCAN 700
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OBO
2023-10-30
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
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OBO
2023-10-20
SPECTRALIS HRA+OCT and variants
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OBO
2023-10-11
Anterion
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OBO
2023-09-01
MS-39
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OBO
2023-08-18
P200TE (A10700)
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OBO
2023-04-13
CIRRUS HD-OCT
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OBO
2023-03-30
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
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OBO
2022-11-09
SOLIX
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OBO
2022-04-27
Tomey Cornea/Anterior Segment OCT CASIA2
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OBO
2021-11-05
Anterion
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OBO
2020-09-09
Spectralis HRA+OCT and variants
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OBO
2020-09-02
OCT-Camera ID 21101A3
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OBO
2019-09-26
Spectralis HRA+OCT and Variants
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OBO
2019-07-31
P200TxE
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OBO
2019-07-24
Canon OCT-A1
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OBO
2019-02-15
CIRRUS HD-OCT
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OBO
2019-01-11
RESCAN 700, CALLISTO eye
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OBO
2018-10-18
Spectralis HRA+OCT and variants with High Magnification Module
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OBO
2018-09-13
Spectralis HRA+OCT and variants with OCT Angiography Module
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OBO
2018-08-30
Spectralis HRA + OCT and variants
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OBO
2018-06-08
Avanti
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OBO
2018-02-28
P200TE
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OBO
2018-01-19
DRI OCT Triton
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OBO
2017-11-01
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
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OBO
2017-06-21
PRIMUS
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OBO
2017-06-09
iVue
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OBO
2017-03-03
3D OCT-1 Maestro
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OBO
2016-12-09
EnFocus 2300, EnFocus 4400
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OBO
2016-10-26
PLEX Elite 9000 SS-OCT
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OBO
2016-07-28
3D OCT-1 Maestro
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OBO
2016-05-06
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
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OBO
2013-03-14
NIDEK RS-3000
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OBO
2013-02-22
OPTOS OCT/SLO MICROPERIMETER
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OBO
2012-10-25
SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
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OBO
2012-06-18
CIRRUS PHOTO
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OBO
2012-01-19
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
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OBO
2011-11-08
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
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OBO
2011-09-08
RTVUE CAM WITH CORNEAL POWER UPGRADE
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OBO
2010-10-01
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
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OBO
2010-04-22
IVUE, MODEL 100
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OBO
2009-09-02
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
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OBO
2009-05-05
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
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OBO
2009-03-13
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
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OBO
2009-01-13
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
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OBO
2008-11-14
SPECTRAL OCT/SLO
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OBO
2008-02-27
SOCT COPERNICUS, MODEL 15205
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OBO
2007-09-28
CA, MODEL: CAM
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OBO
2007-06-22
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
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OBO
2006-10-31
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
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OBO
2006-10-06
RTVUE
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