The following data is part of a premarket notification filed by Gentuity, Llc with the FDA for Gentuity Hf-oct Imaging System With Vis-rx Micro-imaging Catheter.
| Device ID | K192922 |
| 510k Number | K192922 |
| Device Name: | Gentuity HF-OCT Imaging System With Vis-Rx Micro-Imaging Catheter |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776 |
| Contact | David Kolstad |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants LLC 5 Lake Como Ct. Greenville, SC 29609 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-16 |
| Decision Date | 2020-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859910007018 | K192922 | 000 |
| 00859910007032 | K192922 | 000 |
| 00859910007049 | K192922 | 000 |