Tomography, Optical Coherence

Product Code: OBO

Ophthalmic General Optical Products / Medical

Definition: Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 886.1570


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as OBO

4395Tomography, Optical CoherenceOphthalmoscope.

Total Product Life Cycle (TPLC) Devices

4395Tomography, Optical CoherenceOphthalmoscope.

Pre-market Notifications for OBO

K222166SOLIXOptovue, Inc.
K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation
K211817AnterionHeidelberg Engineering GmbH
K201252Spectralis HRA+OCT And VariantsHeidelberg Engineering GmbH
K200516OCT-Camera ID 21101A3OptoMedical Technologies GmbH
K192391Spectralis HRA+OCT And VariantsHeidelberg Engineering GmbH
K190732P200TxEOptos Plc
K182942Canon OCT-A1Canon Inc.
K182569Spectralis HRA+OCT And Variants With High Magnification ModuleHeidelberg Engineering GmbH
K181594Spectralis HRA+OCT And Variants With OCT Angiography ModuleHeidelberg Engineering GmbH
K181534CIRRUS HD-OCTCarl Zeiss Meditec, Inc.
K180660AvantiOptovue, Inc.
K180229RESCAN 700, CALLISTO EyeCarl Zeiss Meditec AG
K173707P200TEOptos Plc
K173648Spectralis HRA + OCT And VariantsHeidelberg Engineering GmbH

Global Unique Device Identification Database

00858848006469Tomography, Optical Coherence
00858848006391Tomography, Optical Coherence
00858848006384Tomography, Optical Coherence
00858848006377Tomography, Optical Coherence
00858848006360Tomography, Optical Coherence
00858848006353Tomography, Optical Coherence
00858848006346Tomography, Optical Coherence
00858848006308Tomography, Optical Coherence
00858848006292Tomography, Optical Coherence
00858848006247Tomography, Optical Coherence
00858848006230Tomography, Optical Coherence
00858848006209Tomography, Optical Coherence
00858848006193Tomography, Optical Coherence
00858848006186Tomography, Optical Coherence
00858848006179Tomography, Optical Coherence

Maude Adverse Events

PLEX ELITE 9000 SS-OCTCARL ZEISS MEDITEC, INC.2018-10-16
CALLISTOCARL ZEISS MEDITEC AG2016-06-02
ZEISS CIRRUSZEISS2013-09-13
SYNERGEYES MULTIFOCAL HYBRID CONTACT LENSSYNERGEYES, INC.2013-07-02
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