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 |
|---|---|---|---|
| Oct 25, 2012 | K121993 | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT Heidelberg Engineering GmbH | OBO |
| Jun 18, 2012 | K112184 | CIRRUS PHOTO Carl Zeiss Meditec, Inc. | OBO |
| Jan 19, 2012 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES Carl Zeiss Meditec, Inc. | OBO |
| Nov 8, 2011 | K113129 | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) Heidelberg Engineering GmbH, DE | OBO |
| Sep 8, 2011 | K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE Optovue, Inc. | OBO |
| Oct 1, 2010 | K101223 | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA Heidelberg Engineering | OBO |
| Apr 22, 2010 | K091404 | IVUE, MODEL 100 Optovue, Inc. | OBO |
| Sep 2, 2009 | K092470 | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 Topcon Corp., JP | OBO |
| May 5, 2009 | K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 Carl Zeiss Meditec, Inc. | OBO |
| Mar 13, 2009 | K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM Topcon Medical Systems, Inc. | OBO |
| Jan 13, 2009 | K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS Topcon Medical Systems, Inc. | OBO |
| Nov 14, 2008 | K080460 | SPECTRAL OCT/SLO Opko Health, Inc. | OBO |
| Feb 27, 2008 | K071839 | SOCT COPERNICUS, MODEL 15205 Reichert, Inc. | OBO |
| Sep 28, 2007 | K071250 | CA, MODEL: CAM Optovue, Inc. | OBO |
| Jun 22, 2007 | K063388 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM Topcon Corp. | OBO |
| Oct 31, 2006 | K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT Heidelberg Engineering, DE | OBO |
| Oct 6, 2006 | K062552 | RTVUE Optovue, Inc. | OBO |
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