K210458 is an FDA 510(k) clearance for the OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System. This device is classified as a System, Imaging, Optical Coherence Tomography (oct) (Class II - Special Controls, product code NQQ).
Submitted by Abbott Medical (Westford, US). The FDA issued a Cleared decision on June 8, 2021, 112 days after receiving the submission on February 16, 2021.
This device falls under the Cardiovascular 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 | K210458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2021 |
| Decision Date | June 08, 2021 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| 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. |