Lightbox L3
The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and…
The Lightbox 3 imaging console is a line-extension of the Lightbox imaging consoles that have been used with catheters in the device families of the Ocelot CTO-crossing catheter system and the Pantheris atherectomy catheter system. The Lightbox 3 console is intended to be used in conjunction with compatible Avinger catheter products by means of an accessory Sled interface to facilitate spinning of fibers at the distal ends of catheters. The Lightbox 3 console houses a laser light source and transmits light to the intraluminal environment through an optical fiber in compatible Avinger products. The Lightbox 3 console receives and interprets the reflected light using a computer to analyze the reflected signal that is returned and processes it in order to present an OCT image of the vessel on the operator monitor in real time.
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 | Avinger, 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) | K212468 |
| Record published | 2024-01-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L300 | 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 Marking Probe 17mm | Ninepoint Medical, Inc. | 1 |
| NvisionVLE Low Profile Imaging Probe, 20mm Working Distance | Ninepoint Medical, Inc. | 1 |
Showing 12 of 56. All products under System, Imaging, Optical Coherence Tomography (Oct)
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.