Luminscan(TM) Disposable Imaging Kit
The LuminScan Disposable Imaging Kit works with the LuminScan console as part of an endoscopic optical coherence tomography imaging system. The system provides cross-sectional, real-time…
The LuminScan Disposable Imaging Kit works with the LuminScan console as part of an endoscopic optical coherence tomography imaging system. The system provides cross-sectional, real-time depth images of human tissue microstructure.
The kit includes a balloon guide sheath with polymer tubing and a closed end. Its balloon inflates to 16 mm and is available in lengths including 80 mm; the probe is 2.5 m long.
Listed Item
The diameter of the balloon is 16mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Balloon Imaging Probe
Testing of the disposable kit covered balloon diameter and length, burst and fatigue, inflation and deflation, tensile strength, endoscopic compatibility, airtightness, retraction, sterilization, and shelf life.
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 | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | NQQ |
| Device type | System, Imaging, Optical Coherence Tomography (Oct) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K162466 |
| Record published | 2023-08-11 |
| Record revised | 2025-12-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, case of 10 |
| Sizes | Balloon length 30 to 80 mm; length 250 cm; balloon diameter 16 to 20 mm; balloon diameter 16 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BOP-16-80-25-7 | Balloon Diameter 16 mm | In distribution |
| BOP-20-55-25-7 | Balloon Diameter 20 mm | In distribution |
| BOP-20-80-25-7 | Balloon Diameter 20 mm | In distribution |
| BOP-16-55-25-7 | Balloon Diameter 16 mm | In distribution |
| BOP-18-80-25-7 | Balloon Diameter 18 mm | In distribution |
| BOP-18-30-25-7 | Balloon Diameter 18 mm | In distribution |
| BOP-16-30-25-7 | Balloon Diameter 16 cm | In distribution |
| BOP-18-55-25-7 | Balloon Diameter 18 mm | In distribution |
| BOP-20-30-25-7 | Balloon Diameter 20 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optis™ | St. Jude Medical | 13 |
| Optis™ | Lightlab Imaging, Inc. | 11 |
| 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 |
| 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 |
|---|---|
| K162466 | 2016-11-29 |
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.