FDA.reportPublic FDA data

Endoscopic optical coherence tomography system probe

Definition
A sterile endoscopic device intended to scan cross-sectional images of tissues within non-vascular luminal structures [e.g., gastrointestinal tract (GI), urinary tract] at a microscopic level. It is a flexible fibreoptic bundle with a rotating distal end designed to emit a light beam whereby real-time, in-depth, high-resolution imagery is produced by means of volumetric laser endomicroscopy (VLE) technology; it may also provide tissue laser marking for visual referencing. It is inserted through the working channel of an endoscope and may be inflated in situ with an inflator; the proximal end connects to the system’s console. It may also be used ex-vivo. This is a single-use device.
GUDID devices
15
Last updated
2019-04-02 02:15:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00859591006027NvisionVLE Imaging Probe 14mmNINEPOINT MEDICAL, INC.95101-142016-09-22
00859591006034NvisionVLE Imaging Probe 17mmNINEPOINT MEDICAL, INC.95101-172016-09-22
00859591006041NvisionVLE Imaging Probe 20mmNINEPOINT MEDICAL, INC.95101-202016-09-22
00859591006058NvisionVLE Marking Probe 14mmNINEPOINT MEDICAL, INC.95301-M-142016-09-22
00859591006065NvisionVLE Marking Probe 17mmNINEPOINT MEDICAL, INC.95301-M-172016-09-22
00859591006072NvisionVLE Marking Probe 20mmNINEPOINT MEDICAL, INC.95301-M-202016-09-22
00859591006126NvisionVLE Marking Probe 17mm Clinical NINEPOINT MEDICAL, INC.95301-M-17C2016-09-22
00859591006133NvisionVLE Marking Probe 20mm Clinical NINEPOINT MEDICAL, INC.95301-M-20C2016-09-22
00859591006140NvisionVLE Marking Probe 14mm Clinical NINEPOINT MEDICAL, INC.95301-M-14C2016-09-22
00859591006157NvisionVLE Imaging Probe 17mm ClinicalNINEPOINT MEDICAL, INC.95101-17C2016-09-22
00859591006164NvisionVLE Imaging Probe 20mm ClinicalNINEPOINT MEDICAL, INC.95101-20C2016-09-22
00859591006171NvisionVLE Imaging Probe 14mm ClinicalNINEPOINT MEDICAL, INC.95101-14C2016-09-22
00859591006188NvisionVLE Low Profile Imaging Probe, 0mm Working DistanceNINEPOINT MEDICAL, INC.95501-LP2016-09-22
00859591006195NvisionVLE Low Profile Imaging Probe, 14mm Working DistanceNINEPOINT MEDICAL, INC.95501-142016-09-22
00859591006201NvisionVLE Low Profile Imaging Probe, 20mm Working DistanceNINEPOINT MEDICAL, INC.95501-202016-09-22