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Review Panel
Diagnostic Devices
CFR Sub-Part
HKX
Tonometer, Ac-Powered
2
Product Code
HKY
Tonometer, Manual
2
Product Code
HKZ
Sterilizer, Tonometer
1
Product Code
HLA
Calibrator, Tonometer
2
Product Code
HLC
Instrument, Measuring, Stereopsis
1
Product Code
HLE
Ruler, Nearpoint (Punctometer)
1
Product Code
HLF
Device, Measuring, Lens Radius, Ophthalmic
1
Product Code
HLG
Pupillometer, Ac-Powered
1
Product Code
HLH
Pupillometer, Manual
1
Product Code
HLI
Ophthalmoscope, Ac-Powered
2
Product Code
HKM
Retinoscope, Battery-Powered
1
Product Code
HKN
Refractor, Manual, Non-Powered, Including Phoropter
1
Product Code
HKO
Refractometer, Ophthalmic
1
Product Code
HKQ
Prism, Rotary, Ophthalmic
1
Product Code
HKR
Lens, Maddox
1
Product Code
HKS
Prism, Gonioscopic
1
Product Code
HKT
Prism, Fresnel, Ophthalmic
1
Product Code
HKW
Prism, Bar, Ophthalmic
1
Product Code
KYH
Endoscope, Ophthalmic
2
Product Code
MPA
Endoilluminator
2
Product Code
NKZ
Endoilluminator, Reprocessed
2
Product Code
HIT
Tester, Color Vision
1
Product Code
HIW
Anomaloscope
1
Product Code
HIX
Maxwell Spot, Ac-Powered
1
Product Code
HIY
Brush, Haidinger, (Including Macular Integrity)
1
Product Code
HJA
Photokeratoscope
1
Product Code
HJB
Instrument, Measuring, Corneal Radius
1
Product Code
HJC
Esthesiometer, Ocular
1
Product Code
HJD
Illuminator, Color Vision Plate
1
Product Code
HJI
Lens, Fundus, Hruby, Diagnostic
1
Product Code
HJJ
Lens, Fresnel, Flexible, Diagnostic
1
Product Code
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
2
Product Code
HJL
Lens, Condensing, Diagnostic
1
Product Code
HJM
Transilluminator, Ac-Powered
2
Product Code
HJN
Transilluminator, Battery-Powered
1
Product Code
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
2
Product Code
HJQ
Stereoscope, Ac-Powered
1
Product Code
HJR
Stereoscope, Battery-Powered
1
Product Code
HJS
Test, Spectacle Dissociation, Ac-Powered (Lancaster)
1
Product Code
HJT
Haploscope
1
Product Code
HJW
Adaptometer (Biophotometer)
1
Product Code
HKD
Tape, Nystagmus
1
Product Code
HKF
Mirror, Headband, Ophthalmic
1
Product Code
HKG
Fornixscope
1
Product Code
HKI
Camera, Ophthalmic, Ac-Powered
2
Product Code
K
21
0197
NFC-600 Automated Portable Retinal Camera
2
Cleared 510(K)
K
20
3500
RetCam Envision
2
Cleared 510(K)
K
20
2097
Fundus Camera
2
Cleared 510(K)
K
20
2221
VX650
2
Cleared 510(K)
K
20
1325
Optomed Smartscope M5 with Optomed Smartscope FA
2
Cleared 510(K)
K
20
1122
Canon non-mydriatic retinal camera CR series
2
Cleared 510(K)
K
19
3319
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
2
Cleared 510(K)
K
20
0254
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
2
Cleared 510(K)
K
19
0954
Fundus Camera
2
Cleared 510(K)
K
19
1945
KOWA nonmyd 8
2
Cleared 510(K)
K
19
0573
KOWA DR-1a
2
Cleared 510(K)
K
19
0198
Microperimeter MP-3, Microperimeter MP-3 Type S
2
Cleared 510(K)
K
18
2199
NFC-700 non-mydriatic auto fundus camera
2
Cleared 510(K)
K
18
3059
3nethra neo
2
Cleared 510(K)
K
18
2506
LipiScan Dynamic Meibomian Imager
2
Cleared 510(K)
K
18
2263
RetCam 3 ; RetCam Shuttle ; RetCam Portable
2
Cleared 510(K)
K
17
3474
RetiCapture
2
Cleared 510(K)
K
18
0306
Nexy
2
Cleared 510(K)
K
18
0378
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
2
Cleared 510(K)
K
17
0527
Phoenix Clinical ICON
2
Cleared 510(K)
K
16
3021
HAAG-STREIT FUNDUS MODULE 300
2
Cleared 510(K)
K
16
1727
Eyenez Ophthalmic Camera
2
Cleared 510(K)
K
15
2729
MICROPERIMETER MP-3
2
Cleared 510(K)
K
15
3239
LSFG-NAVI
2
Cleared 510(K)
K
15
2869
LipiView II Ocular Surface Interferometer
2
Cleared 510(K)
K
14
1325
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
14
1481
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
13
2987
COBRA FUNDUS CAMERA
2
Cleared 510(K)
K
14
0450
KEELER KAPTURE SOFTWARE
2
Cleared 510(K)
K
13
2186
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
2
Cleared 510(K)
K
13
0656
IFUSION
2
Cleared 510(K)
K
12
3101
TRC-50DX RETINAL CAMERA
2
Cleared 510(K)
K
13
0289
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
12
3208
DIGITAL RETINAL CAMERA
2
Cleared 510(K)
K
12
3460
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
12
2572
ICAM FUNDUS CAMERA
2
Cleared 510(K)
K
12
2481
LIPIVIEW OCULAR SURFACE INTERFEROMETER
2
Cleared 510(K)
K
12
1405
PANOPTIC
2
Cleared 510(K)
K
12
0982
DIGITAL EYE-FUNDUS CAMERA
2
Cleared 510(K)
K
11
3451
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
2
Cleared 510(K)
K
11
2330
KOWA VX-20
2
Cleared 510(K)
K
11
1771
NON-CONTACT TEAR FILM THERMOGRAGH
2
Cleared 510(K)
K
11
1612
DIGITAL RETINAL CAMERA
2
Cleared 510(K)
K
10
2412
VISTA DIGITAL OPTHALMOSCOPE
2
Cleared 510(K)
K
11
0986
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
2
Cleared 510(K)
K
10
2859
RETCAM 3 OPTHALMIC IMAGING SYSTEM
2
Cleared 510(K)
K
10
1628
KOWA NONMYD WX
2
Cleared 510(K)
K
10
2651
ISCREEN VISION SCREENER
2
Cleared 510(K)
K
10
1861
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
2
Cleared 510(K)
K
09
3071
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
2
Cleared 510(K)
K
10
2013
DIGITAL RETINAL CAMERA
2
Cleared 510(K)
K
10
1935
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
2
Cleared 510(K)
K
09
2565
DIGITAL RETINAL CAMERA CX-1
2
Cleared 510(K)
K
10
0207
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
2
Cleared 510(K)
K
09
0326
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
2
Cleared 510(K)
K
09
2374
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
2
Cleared 510(K)
K
09
1935
LIPIVIEW OCULAR SURFACE INTERFEROMETER
2
Cleared 510(K)
K
09
2056
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
2
Cleared 510(K)
K
09
1098
KOWAGENESIS-DF
2
Cleared 510(K)
K
09
1683
KOWA VX-10 A
2
Cleared 510(K)
K
09
0115
RETINA CAMERA TRC-NW7SF MARK II
2
Cleared 510(K)
K
08
2196
STATIC VESSEL ANALYZER
2
Cleared 510(K)
K
09
0466
DIGITAL RETINAL CAMERA, CR-1 MARK II
2
Cleared 510(K)
K
08
3771
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
2
Cleared 510(K)
K
08
3387
MODIFICATION TO KOWA NONMYD ALPHA-DIII
2
Cleared 510(K)
K
08
1858
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
2
Cleared 510(K)
K
08
2767
KOWA NONMYD ALPHA-DIII
2
Cleared 510(K)
K
08
0180
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
2
Cleared 510(K)
K
08
0883
CR-1
2
Cleared 510(K)
K
08
0681
KOWA GENESIS-D
2
Cleared 510(K)
K
07
0231
ORION
2
Cleared 510(K)
K
06
3717
CF-1
2
Cleared 510(K)
K
06
2416
RETINAL FUNCTIONAL IMAGER (RFI)
2
Cleared 510(K)
K
06
2021
KOWA VX-10I
2
Cleared 510(K)
K
06
2295
IRI INTEGRATED RETINAL IMAGER
2
Cleared 510(K)
K
06
1768
MP-1 MICROPERIMETER
2
Cleared 510(K)
K
06
2356
KOWA NONMYD ALPHA-D
2
Cleared 510(K)
K
05
3044
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
2
Cleared 510(K)
K
05
3026
KOWA NONMYD 7, KOWA NONMYD A-D
2
Cleared 510(K)
K
05
0271
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
2
Cleared 510(K)
K
05
2268
VISUCAM PRO NM
2
Cleared 510(K)
K
04
3213
KOWA VX-10
2
Cleared 510(K)
K
04
3222
VISCUCAM C DIGITAL CAMERA
2
Cleared 510(K)
K
04
1367
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
04
1546
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
2
Cleared 510(K)
K
04
0325
PANORET, MODEL PNM 60
2
Cleared 510(K)
K
03
1629
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
2
Cleared 510(K)
K
02
3719
MP-1 MICRO PERIMETER
2
Cleared 510(K)
K
02
0888
FUNDUS AUTOIMAGER
2
Cleared 510(K)
K
02
2164
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
2
Cleared 510(K)
K
01
4274
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
2
Cleared 510(K)
K
01
1877
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
2
Cleared 510(K)
K
01
0315
ISCREEN VISION SCREENER
2
Cleared 510(K)
K
00
2920
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
2
Cleared 510(K)
K
00
3236
RETINADX
2
Cleared 510(K)
K
00
1275
RETCAM II
2
Cleared 510(K)
K
00
0368
EYECAP IMAGING SYSTEM
2
Cleared 510(K)
K
99
0205
DIGISCOPE OPHTHALMIC CAMERA
2
Cleared 510(K)
K
98
2689
WINSTATION RETINAL IMAGER
2
Cleared 510(K)
K
97
4535
DISCAM DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
98
0295
OPHTHAVISION IMAGING SYSTEM
2
Cleared 510(K)
K
98
0246
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
2
Cleared 510(K)
K
98
0357
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
2
Cleared 510(K)
K
97
3950
RETINAL CUBE
2
Cleared 510(K)
K
97
3533
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
2
Cleared 510(K)
K
97
3218
NIDEK HANDY
2
Cleared 510(K)
K
97
2440
CATARACTSCREENER CT - S
2
Cleared 510(K)
K
97
1685
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
2
Cleared 510(K)
K
96
3333
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
2
Cleared 510(K)
K
95
5442
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
2
Cleared 510(K)
K
95
4781
KOWA GENESIS HAND-HELD FUNDUS CAMERA
2
Cleared 510(K)
K
95
4780
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
2
Cleared 510(K)
K
95
3972
ANGIOVISION VIEWING STATION
2
Cleared 510(K)
K
95
3973
ANGIOVISION 1000
2
Cleared 510(K)
K
95
2480
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
2
Cleared 510(K)
K
94
1234
NON-MYDRIATIC RETINAL CAMERA
2
Cleared 510(K)
K
95
0091
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
2
Cleared 510(K)
K
94
6058
60 FUNDUS CAMERA CF-60UV
2
Cleared 510(K)
K
93
4663
60 DEGREE FUNDUS CAMERA, CF-60UD
2
Cleared 510(K)
K
93
0442
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS
2
Cleared 510(K)
K
92
3708
LEMPERT OPTIC DISC ANALYSIS SYSTEM
2
Cleared 510(K)
K
92
3958
CHROMOS IMAGER
2
Cleared 510(K)
K
91
3314
CANDELA RETINAL CAMERA
2
Cleared 510(K)
K
91
3929
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
2
Cleared 510(K)
K
91
1439
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
2
Cleared 510(K)
K
89
5474
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
2
Cleared 510(K)
K
88
4989
NEVISCAN MODEL N - 100
2
Cleared 510(K)
K
87
4355
OPACITY LENSMETER 701
2
Cleared 510(K)
K
87
4017
MODIFIED RETINAL CAMERA MODEL CR4-45NM
2
Cleared 510(K)
K
87
3157
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
2
Cleared 510(K)
K
86
2323
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
2
Cleared 510(K)
K
85
5170
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
2
Cleared 510(K)
K
85
4330
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
2
Cleared 510(K)
K
85
2638
HUMPHREY IMAGE ANALYZER MODEL 110
2
Cleared 510(K)
K
84
3899
GRC-WT, GRC-W
2
Cleared 510(K)
K
84
4898
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
2
Cleared 510(K)
K
84
3021
CANON 60 FUNDUS CAMERA CF-60U
2
Cleared 510(K)
K
83
3694
TEXAS BIO SCAN
2
Cleared 510(K)
K
82
2991
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
2
Cleared 510(K)
K
82
3719
AML (ANGLE MAGNIFYING LENS
2
Cleared 510(K)
K
82
2908
COHERENT FUNDUSL RETINAL CAMERA
2
Cleared 510(K)
K
77
0888
POMERANTZEFF EQUATOR PLUS CAMERA
2
Cleared 510(K)
HKL
Retinoscope, Ac-Powered
2
Product Code
HLJ
Ophthalmoscope, Battery-Powered
2
Product Code
HLK
Screen, Tangent, Target, Battery-Powered
1
Product Code
HLL
Monitor, Eye Movement
2
Product Code
HLM
Instrument, Measuring, Lens, Ac-Powered
1
Product Code
HLN
Gauge, Lens, Ophthalmic
1
Product Code
HLO
Test, Spectacle Dissociation, Battery-Powered (Lancaster)
1
Product Code
HLP
Target, Fusion And Stereoscopic
1
Product Code
HLQ
Keratoscope, Ac-Powered
1
Product Code
HLR
Keratoscope, Battery-Powered
1
Product Code
HLS
Exophthalmometer
1
Product Code
HLT
Preamplifier, Ac-Powered, Ophthalmic
2
Product Code
HLW
Preamplifier, Battery-Powered, Ophthalmic
2
Product Code
HLX
Photostimulator, Ac-Powered
2
Product Code
HLZ
Electrode, Corneal
2
Product Code
HMC
Monitor, Eye Movement, Diagnostic
2
Product Code
HMD
Chair, Ophthalmic, Manual
1
Product Code
HME
Chair, Ophthalmic, Ac-Powered
1
Product Code
HMF
Stand, Instrument, Ac-Powered, Ophthalmic
1
Product Code
HMG
Stand, Instrument, Ophthalmic, Non-Powered
1
Product Code
HMH
Rack, Skiascopic
1
Product Code
HMJ
Screen, Tangent, Projection, Battery-Powered
1
Product Code
HMK
Euthyscope, Ac-Powered
2
Product Code
HML
Euthyscope, Battery-Powered
1
Product Code
HMM
Distometer
1
Product Code
HOJ
Screen, Tangent, Target
1
Product Code
HOK
Screen, Tangent, Projection, Ac-Powered
1
Product Code
HOL
Screen, Tangent, Felt (Campimeter)
1
Product Code
HOM
Screen, Tangent, Ac-Powered (Campimeter)
1
Product Code
HON
Perimeter, Manual
1
Product Code
HOO
Perimeter, Ac-Powered
1
Product Code
HOP
Campimeter, Stereo, Battery-Powered
1
Product Code
HOQ
Grid, Amsler
1
Product Code
HOR
Simulatan (Including Crossed Cylinder)
1
Product Code
HOS
Projector, Ophthalmic
1
Product Code
HOW
Drum, Opticokinetic
1
Product Code
HOX
Chart, Visual Acuity
1
Product Code
HPA
Frame, Trial, Ophthalmic
1
Product Code
HPB
Clip, Lens, Trial, Ophthalmic
1
Product Code
HPC
Set, Lens, Trial, Ophthalmic
1
Product Code
HPD
Lens, Bagolini
1
Product Code
HPJ
Instrument, Visual Field, Laser
2
Product Code
HPK
Tonograph
2
Product Code
HPL
Device, Fixation, Ac-Powered, Ophthalmic
1
Product Code
HPT
Perimeter, Automatic, Ac-Powered
1
Product Code
HPW
Probe And Counter, Isotope, For Phosphorus 32
2
Product Code
HRE
Cabinet, Instrument, Ac-Powered, Ophthalmic
1
Product Code
HRI
Pupillograph
1
Product Code
KYD
Strip, Schirmer
1
Product Code
MMF
Photorefractor
2
Product Code
MMQ
Topographer, Corneal, Ac-Powered
1
Product Code
MSG
Ophthalmoscopes, Replacement Batteries, Hand-Held
2
Product Code
MXK
Device, Analysis, Anterior Segment
2
Product Code
MYC
Ophthalmoscope, Laser, Scanning
2
Product Code
NCF
Aberrometer, Ophthalmic
1
Product Code
NFD
Selector, Color, Spectacle, Lens, Tint
1
Product Code
NJG
Flasher, Afterimage, Ophthalmic
2
Product Code
NJJ
Tonometer, Analyzer, Ocular Blood Flow
2
Product Code
NOG
Topographer, Corneal, Battery Powered
1
Product Code
NOH
Photokeratoscope, Battery Powered
1
Product Code
NOI
Stand, Instrument, Ophthalmic, Battery Powered
1
Product Code
NQE
Microscope, Specular
2
Product Code
NXR
Fixation, Vision Training, Binocular
1
Product Code
NYK
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
2
Product Code
OBO
Tomography, Optical Coherence
2
Product Code
OUM
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
1
Product Code
PIB
Diabetic Retinopathy Detection Device
2
Product Code
PJZ
Camera, Ophthalmic, General-Use
2
Product Code
PLZ
Ocular Pattern Recorder
2
Product Code
PMW
Strabismus Detection Device
2
Product Code
PUE
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
2
Product Code
QER
Camera, Ophthalmic, Slit-Scanning
2
Product Code
NFF
Device, Storage, Images, Ophthalmic
1
Product Code
NFG
Device, Communications, Images, Ophthalmic
1
Product Code
NFH
Digitizer, Images, Ophthalmic
2
Product Code
NFI
Device, Hardcopy, Images, Ophthalmic
2
Product Code
NFJ
System, Image Management, Ophthalmic
2
Product Code
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 June 2023 at 11:04 pm
OP
/
diagnostic-devices
/
HKI
/
K180378
View Source
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180378
510(k) Type
Traditional
Applicant
Optomed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
4/5/2018
Days to Decision
52 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
HKX
Tonometer, Ac-Powered
HKY
Tonometer, Manual
HKZ
Sterilizer, Tonometer
HLA
Calibrator, Tonometer
HLC
Instrument, Measuring, Stereopsis
HLE
Ruler, Nearpoint (Punctometer)
HLF
Device, Measuring, Lens Radius, Ophthalmic
HLG
Pupillometer, Ac-Powered
HLH
Pupillometer, Manual
HLI
Ophthalmoscope, Ac-Powered
HKM
Retinoscope, Battery-Powered
HKN
Refractor, Manual, Non-Powered, Including Phoropter
HKO
Refractometer, Ophthalmic
HKQ
Prism, Rotary, Ophthalmic
HKR
Lens, Maddox
HKS
Prism, Gonioscopic
HKT
Prism, Fresnel, Ophthalmic
HKW
Prism, Bar, Ophthalmic
KYH
Endoscope, Ophthalmic
MPA
Endoilluminator
NKZ
Endoilluminator, Reprocessed
HIT
Tester, Color Vision
HIW
Anomaloscope
HIX
Maxwell Spot, Ac-Powered
HIY
Brush, Haidinger, (Including Macular Integrity)
HJA
Photokeratoscope
HJB
Instrument, Measuring, Corneal Radius
HJC
Esthesiometer, Ocular
HJD
Illuminator, Color Vision Plate
HJI
Lens, Fundus, Hruby, Diagnostic
HJJ
Lens, Fresnel, Flexible, Diagnostic
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
HJL
Lens, Condensing, Diagnostic
HJM
Transilluminator, Ac-Powered
HJN
Transilluminator, Battery-Powered
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
HJQ
Stereoscope, Ac-Powered
HJR
Stereoscope, Battery-Powered
HJS
Test, Spectacle Dissociation, Ac-Powered (Lancaster)
HJT
Haploscope
HJW
Adaptometer (Biophotometer)
HKD
Tape, Nystagmus
HKF
Mirror, Headband, Ophthalmic
HKG
Fornixscope
HKI
Camera, Ophthalmic, Ac-Powered
K
21
0197
NFC-600 Automated Portable Retinal Camera
K
20
3500
RetCam Envision
K
20
2097
Fundus Camera
K
20
2221
VX650
K
20
1325
Optomed Smartscope M5 with Optomed Smartscope FA
K
20
1122
Canon non-mydriatic retinal camera CR series
K
19
3319
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
K
20
0254
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
K
19
0954
Fundus Camera
K
19
1945
KOWA nonmyd 8
K
19
0573
KOWA DR-1a
K
19
0198
Microperimeter MP-3, Microperimeter MP-3 Type S
K
18
2199
NFC-700 non-mydriatic auto fundus camera
K
18
3059
3nethra neo
K
18
2506
LipiScan Dynamic Meibomian Imager
K
18
2263
RetCam 3 ; RetCam Shuttle ; RetCam Portable
K
17
3474
RetiCapture
K
18
0306
Nexy
K
18
0378
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K
17
0527
Phoenix Clinical ICON
K
16
3021
HAAG-STREIT FUNDUS MODULE 300
K
16
1727
Eyenez Ophthalmic Camera
K
15
2729
MICROPERIMETER MP-3
K
15
3239
LSFG-NAVI
K
15
2869
LipiView II Ocular Surface Interferometer
K
14
1325
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K
14
1481
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K
13
2987
COBRA FUNDUS CAMERA
K
14
0450
KEELER KAPTURE SOFTWARE
K
13
2186
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K
13
0656
IFUSION
K
12
3101
TRC-50DX RETINAL CAMERA
K
13
0289
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K
12
3208
DIGITAL RETINAL CAMERA
K
12
3460
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
K
12
2572
ICAM FUNDUS CAMERA
K
12
2481
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K
12
1405
PANOPTIC
K
12
0982
DIGITAL EYE-FUNDUS CAMERA
K
11
3451
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
K
11
2330
KOWA VX-20
K
11
1771
NON-CONTACT TEAR FILM THERMOGRAGH
K
11
1612
DIGITAL RETINAL CAMERA
K
10
2412
VISTA DIGITAL OPTHALMOSCOPE
K
11
0986
OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
K
10
2859
RETCAM 3 OPTHALMIC IMAGING SYSTEM
K
10
1628
KOWA NONMYD WX
K
10
2651
ISCREEN VISION SCREENER
K
10
1861
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
K
09
3071
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
K
10
2013
DIGITAL RETINAL CAMERA
K
10
1935
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
K
09
2565
DIGITAL RETINAL CAMERA CX-1
K
10
0207
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K
09
0326
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
K
09
2374
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
K
09
1935
LIPIVIEW OCULAR SURFACE INTERFEROMETER
K
09
2056
OPTOMED SMARTSCOPE, MODEL M3-1 EY1
K
09
1098
KOWAGENESIS-DF
K
09
1683
KOWA VX-10 A
K
09
0115
RETINA CAMERA TRC-NW7SF MARK II
K
08
2196
STATIC VESSEL ANALYZER
K
09
0466
DIGITAL RETINAL CAMERA, CR-1 MARK II
K
08
3771
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
K
08
3387
MODIFICATION TO KOWA NONMYD ALPHA-DIII
K
08
1858
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K
08
2767
KOWA NONMYD ALPHA-DIII
K
08
0180
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K
08
0883
CR-1
K
08
0681
KOWA GENESIS-D
K
07
0231
ORION
K
06
3717
CF-1
K
06
2416
RETINAL FUNCTIONAL IMAGER (RFI)
K
06
2021
KOWA VX-10I
K
06
2295
IRI INTEGRATED RETINAL IMAGER
K
06
1768
MP-1 MICROPERIMETER
K
06
2356
KOWA NONMYD ALPHA-D
K
05
3044
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K
05
3026
KOWA NONMYD 7, KOWA NONMYD A-D
K
05
0271
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K
05
2268
VISUCAM PRO NM
K
04
3213
KOWA VX-10
K
04
3222
VISCUCAM C DIGITAL CAMERA
K
04
1367
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K
04
1546
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K
04
0325
PANORET, MODEL PNM 60
K
03
1629
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K
02
3719
MP-1 MICRO PERIMETER
K
02
0888
FUNDUS AUTOIMAGER
K
02
2164
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM
K
01
4274
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K
01
1877
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
K
01
0315
ISCREEN VISION SCREENER
K
00
2920
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K
00
3236
RETINADX
K
00
1275
RETCAM II
K
00
0368
EYECAP IMAGING SYSTEM
K
99
0205
DIGISCOPE OPHTHALMIC CAMERA
K
98
2689
WINSTATION RETINAL IMAGER
K
97
4535
DISCAM DIGITAL IMAGING SYSTEM
K
98
0295
OPHTHAVISION IMAGING SYSTEM
K
98
0246
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K
98
0357
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K
97
3950
RETINAL CUBE
K
97
3533
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
K
97
3218
NIDEK HANDY
K
97
2440
CATARACTSCREENER CT - S
K
97
1685
IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM
K
96
3333
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
K
95
5442
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K
95
4781
KOWA GENESIS HAND-HELD FUNDUS CAMERA
K
95
4780
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
K
95
3972
ANGIOVISION VIEWING STATION
K
95
3973
ANGIOVISION 1000
K
95
2480
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
K
94
1234
NON-MYDRIATIC RETINAL CAMERA
K
95
0091
KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
K
94
6058
60 FUNDUS CAMERA CF-60UV
K
93
4663
60 DEGREE FUNDUS CAMERA, CF-60UD
K
93
0442
MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS
K
92
3708
LEMPERT OPTIC DISC ANALYSIS SYSTEM
K
92
3958
CHROMOS IMAGER
K
91
3314
CANDELA RETINAL CAMERA
K
91
3929
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
K
91
1439
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K
89
5474
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K
88
4989
NEVISCAN MODEL N - 100
K
87
4355
OPACITY LENSMETER 701
K
87
4017
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K
87
3157
OXFORD RETRO-ILLUMINATION CATARACT CAMERA
K
86
2323
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K
85
5170
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K
85
4330
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM
K
85
2638
HUMPHREY IMAGE ANALYZER MODEL 110
K
84
3899
GRC-WT, GRC-W
K
84
4898
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K
84
3021
CANON 60 FUNDUS CAMERA CF-60U
K
83
3694
TEXAS BIO SCAN
K
82
2991
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K
82
3719
AML (ANGLE MAGNIFYING LENS
K
82
2908
COHERENT FUNDUSL RETINAL CAMERA
K
77
0888
POMERANTZEFF EQUATOR PLUS CAMERA
HKL
Retinoscope, Ac-Powered
HLJ
Ophthalmoscope, Battery-Powered
HLK
Screen, Tangent, Target, Battery-Powered
HLL
Monitor, Eye Movement
HLM
Instrument, Measuring, Lens, Ac-Powered
HLN
Gauge, Lens, Ophthalmic
HLO
Test, Spectacle Dissociation, Battery-Powered (Lancaster)
HLP
Target, Fusion And Stereoscopic
HLQ
Keratoscope, Ac-Powered
HLR
Keratoscope, Battery-Powered
HLS
Exophthalmometer
HLT
Preamplifier, Ac-Powered, Ophthalmic
HLW
Preamplifier, Battery-Powered, Ophthalmic
HLX
Photostimulator, Ac-Powered
HLZ
Electrode, Corneal
HMC
Monitor, Eye Movement, Diagnostic
HMD
Chair, Ophthalmic, Manual
HME
Chair, Ophthalmic, Ac-Powered
HMF
Stand, Instrument, Ac-Powered, Ophthalmic
HMG
Stand, Instrument, Ophthalmic, Non-Powered
HMH
Rack, Skiascopic
HMJ
Screen, Tangent, Projection, Battery-Powered
HMK
Euthyscope, Ac-Powered
HML
Euthyscope, Battery-Powered
HMM
Distometer
HOJ
Screen, Tangent, Target
HOK
Screen, Tangent, Projection, Ac-Powered
HOL
Screen, Tangent, Felt (Campimeter)
HOM
Screen, Tangent, Ac-Powered (Campimeter)
HON
Perimeter, Manual
HOO
Perimeter, Ac-Powered
HOP
Campimeter, Stereo, Battery-Powered
HOQ
Grid, Amsler
HOR
Simulatan (Including Crossed Cylinder)
HOS
Projector, Ophthalmic
HOW
Drum, Opticokinetic
HOX
Chart, Visual Acuity
HPA
Frame, Trial, Ophthalmic
HPB
Clip, Lens, Trial, Ophthalmic
HPC
Set, Lens, Trial, Ophthalmic
HPD
Lens, Bagolini
HPJ
Instrument, Visual Field, Laser
HPK
Tonograph
HPL
Device, Fixation, Ac-Powered, Ophthalmic
HPT
Perimeter, Automatic, Ac-Powered
HPW
Probe And Counter, Isotope, For Phosphorus 32
HRE
Cabinet, Instrument, Ac-Powered, Ophthalmic
HRI
Pupillograph
KYD
Strip, Schirmer
MMF
Photorefractor
MMQ
Topographer, Corneal, Ac-Powered
MSG
Ophthalmoscopes, Replacement Batteries, Hand-Held
MXK
Device, Analysis, Anterior Segment
MYC
Ophthalmoscope, Laser, Scanning
NCF
Aberrometer, Ophthalmic
NFD
Selector, Color, Spectacle, Lens, Tint
NJG
Flasher, Afterimage, Ophthalmic
NJJ
Tonometer, Analyzer, Ocular Blood Flow
NOG
Topographer, Corneal, Battery Powered
NOH
Photokeratoscope, Battery Powered
NOI
Stand, Instrument, Ophthalmic, Battery Powered
NQE
Microscope, Specular
NXR
Fixation, Vision Training, Binocular
NYK
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
OBO
Tomography, Optical Coherence
OUM
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
PIB
Diabetic Retinopathy Detection Device
PJZ
Camera, Ophthalmic, General-Use
PLZ
Ocular Pattern Recorder
PMW
Strabismus Detection Device
PUE
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
QER
Camera, Ophthalmic, Slit-Scanning
NFF
Device, Storage, Images, Ophthalmic
NFG
Device, Communications, Images, Ophthalmic
NFH
Digitizer, Images, Ophthalmic
NFI
Device, Hardcopy, Images, Ophthalmic
NFJ
System, Image Management, Ophthalmic
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
diagnostic-devices
/
HKI
/
K180378
View Source
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180378
510(k) Type
Traditional
Applicant
Optomed Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
4/5/2018
Days to Decision
52 days
Submission Type
Summary