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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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General and Plastic Surgery
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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
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2
Product Code
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2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
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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
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)
Show All 32 Submissions
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
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1
Product Code
JYK
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1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Neurological Surgical Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 26 May 2023 at 11:04 pm
SU
/
diagnostic-devices
/
NQQ
/
K182616
View Source
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182616
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/2/2018
Days to Decision
42 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
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
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
Show All 32 Submissions
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
General Hospital and Personal Use Monitoring Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Neurological Surgical Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
diagnostic-devices
/
NQQ
/
K182616
View Source
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182616
510(k) Type
Traditional
Applicant
NinePoint Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
11/2/2018
Days to Decision
42 days
Submission Type
Summary