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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
OWN
Confocal Optical Imaging
2
Product Code
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
K
24
0610
deepLive
2
Cleared 510(K)
K
23
2386
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
2
Cleared 510(K)
K
23
0691
HyperVue™ Imaging System
2
Cleared 510(K)
K
22
1257
SpectraWAVE Imaging System
2
Cleared 510(K)
K
21
0458
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
2
Cleared 510(K)
K
20
3578
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
2
Cleared 510(K)
K
20
1552
ApolloVue S100 Image System
2
Cleared 510(K)
K
19
2922
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
2
Cleared 510(K)
K
19
1117
NvisionVLE Low-profile Optical Probe
2
Cleared 510(K)
K
18
3320
Ilumien Optis, Optis Integrated, Optis Mobile
2
Cleared 510(K)
K
19
0404
OTIS Optical Coherence Tomography SYstem
2
Cleared 510(K)
K
18
2616
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
2
Cleared 510(K)
K
18
2261
NvisionVLE Imaging System, NvisionVLE Optical Probe
2
Cleared 510(K)
K
17
1560
OTIS Optical Coherence Tomography System
2
Cleared 510(K)
K
16
2466
LuminScan (TM) Imaging System
2
Cleared 510(K)
K
15
3283
VivoSight Dx Topical OCT System
2
Cleared 510(K)
K
16
0878
OPTIS Metallic Stent Optimization E.4 SW
2
Cleared 510(K)
K
16
0240
Perimeter Otis™ 1.0 Optical Coherence Tomography System
2
Cleared 510(K)
K
15
3479
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
2
Cleared 510(K)
K
15
2120
OPTIS Mobile System
2
Cleared 510(K)
K
15
1286
OPTIS Integrated System Mobile Workstation
2
Cleared 510(K)
K
15
0878
ILUMIEN OPTIS
2
Cleared 510(K)
K
15
0237
ILUMIEN, Drageonfly OPTIS Imaging Catheter
2
Cleared 510(K)
K
14
3678
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
2
Cleared 510(K)
K
13
3209
FORESEE (4C) IMAGING SYSTEM
2
Cleared 510(K)
K
13
2800
SKINTELL
2
Cleared 510(K)
K
12
0800
NVISION VLE IMAGING SYSTEM
2
Cleared 510(K)
K
12
3369
ILUMIEN OPTIS
2
Cleared 510(K)
K
12
1195
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
2
Cleared 510(K)
K
11
2770
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
2
Cleared 510(K)
K
11
1201
C7 XR IMAGING SYSTEM
2
Cleared 510(K)
K
10
2599
TOMOPHASE OCTIS
2
Cleared 510(K)
K
09
3857
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
2
Cleared 510(K)
K
09
3520
VIVOSIGHT TOPICAL OCT SYSTEM
2
Cleared 510(K)
K
04
2894
IMALUX NIRIS IMAGING SYSTEM
2
Cleared 510(K)
K
03
3783
IMALUX OCT IMAGING SYSTEM
2
Cleared 510(K)
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
QZB
Software Controlled Endoscope And Instrument Holder
2
Product Code
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-b—diagnostic-devices
/
NQQ
/
K033783
View Source
IMALUX OCT IMAGING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033783
510(k) Type
Traditional
Applicant
IMALUX COPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2004
Days to Decision
88 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
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
MFJ
Device, Endoscopic Suturing
EPY
Speculum, Ent
NAY
System, Surgical, Computer Controlled Instrument
NEQ
Device, Telemedicine, Robotic
PDT
Burn Resuscitation Decision Support Software
FDP
Apparatus, Pneumoperitoneum, Automatic
GCG
Peritoneoscope
GCH
Mediastinoscope, Diagnostic
OTJ
Laparoscopic Single Port Access Device
OWN
Confocal Optical Imaging
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
K
24
0610
deepLive
K
23
2386
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
K
23
0691
HyperVue™ Imaging System
K
22
1257
SpectraWAVE Imaging System
K
21
0458
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K
20
3578
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
K
20
1552
ApolloVue S100 Image System
K
19
2922
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K
19
1117
NvisionVLE Low-profile Optical Probe
K
18
3320
Ilumien Optis, Optis Integrated, Optis Mobile
K
19
0404
OTIS Optical Coherence Tomography SYstem
K
18
2616
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K
18
2261
NvisionVLE Imaging System, NvisionVLE Optical Probe
K
17
1560
OTIS Optical Coherence Tomography System
K
16
2466
LuminScan (TM) Imaging System
K
15
3283
VivoSight Dx Topical OCT System
K
16
0878
OPTIS Metallic Stent Optimization E.4 SW
K
16
0240
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K
15
3479
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
K
15
2120
OPTIS Mobile System
K
15
1286
OPTIS Integrated System Mobile Workstation
K
15
0878
ILUMIEN OPTIS
K
15
0237
ILUMIEN, Drageonfly OPTIS Imaging Catheter
K
14
3678
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
K
13
3209
FORESEE (4C) IMAGING SYSTEM
K
13
2800
SKINTELL
K
12
0800
NVISION VLE IMAGING SYSTEM
K
12
3369
ILUMIEN OPTIS
K
12
1195
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
K
11
2770
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
K
11
1201
C7 XR IMAGING SYSTEM
K
10
2599
TOMOPHASE OCTIS
K
09
3857
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
K
09
3520
VIVOSIGHT TOPICAL OCT SYSTEM
K
04
2894
IMALUX NIRIS IMAGING SYSTEM
K
03
3783
IMALUX OCT IMAGING SYSTEM
POY
Post Breast Biopsy Hemostatic Breast Compression Device
FXE
Speculum, Non-Illuminated
FXF
Speculum, Illuminated
FXG
Specula Accessories
JYK
Holder, Ear Speculum
KAG
Holder, Speculum, Ent
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
QZB
Software Controlled Endoscope And Instrument Holder
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-b—diagnostic-devices
/
NQQ
/
K033783
View Source
IMALUX OCT IMAGING SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K033783
510(k) Type
Traditional
Applicant
IMALUX COPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/1/2004
Days to Decision
88 days
Submission Type
Summary