K143678 is an FDA 510(k) clearance for the NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory. This device is classified as a System, Imaging, Optical Coherence Tomography (oct) (Class II - Special Controls, product code NQQ).
Submitted by Ninepoint Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 6, 2015, 44 days after receiving the submission on December 24, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1560. This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging..
| 510(k) Number | K143678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 24, 2014 |
| Decision Date | February 06, 2015 |
| Days to Decision | 44 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NQQ - System, Imaging, Optical Coherence Tomography (oct) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
| Definition | This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging. |