NvisionVLE Marking Probe 17mm
NvisionVLE Marking Probe 17mm is a sterile, single-use probe used with the NvisionVLE Imaging System to image tissue microstructure and mark regions of interest. It passes through an…
NvisionVLE Marking Probe 17mm is a sterile, single-use probe used with the NvisionVLE Imaging System to image tissue microstructure and mark regions of interest. It passes through an endoscope’s working channel.
The system uses swept-source optical coherence tomography to form real-time cross-sectional images. An integrated 1470 nm laser can create temporary reference marks after the operator identifies a tissue region on the image.
Probe Placement and Limits
A separate sterile inflation system inflates the probe balloon for placement, while a probe-lock accessory limits longitudinal movement during marking. Imaging includes esophageal tissue microstructure; diagnostic differentiation of normal tissue from specific abnormalities has not been established.
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Ninepoint Medical, Inc., United States |
|---|---|
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| 510(k) | K153479 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature -28 to 50 °C; Handling environment humidity 15 to 85 % RH |
| Sizes | Outer diameter 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95301-M-17 | Outer Diameter 17 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Optis™ | Lightlab Imaging, Inc. | 11 |
| Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 9 |
| Ilumien™ | Lightlab Imaging, Inc. | 6 |
| Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device&Technology Co., Ltd. | 2 |
| VivoSight | Michelson Diagnostics Ltd | 2 |
| AptiVue™ | Lightlab Imaging, Inc. | 2 |
| Pantheris | Avinger, Inc. | 2 |
| NvisionVLE Imaging Console | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Imaging Console Refurbished | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | Ninepoint Medical, Inc. | 1 |
| S-Series OCT | Perimeter Medical Imaging AI, Inc. | 1 |
Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191117 | 2019-07-19 |
| K182616 | 2018-11-02 |
| K182261 | 2018-10-16 |
| K153479 | 2016-02-16 |
| K143678 | 2015-02-06 |
| K120800 | 2013-04-25 |
| K121195 | 2012-07-25 |
| K112770 | 2011-12-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-04-11 | Class II | Process control | Distal tips of the probes may detach from the probe shaft during use. | 152 | 2018-08-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.