The following data is part of a premarket notification filed by Altaravision Inc. with the FDA for Ndohd High Definition Imaging System (ndohd).
| Device ID | K190420 |
| 510k Number | K190420 |
| Device Name: | NDOHD High Definition Imaging System (NDOHD) |
| Classification | System, Image Processing, Radiological |
| Applicant | Altaravision Inc. 130 Salem Town Court Apex, NC 27502 |
| Contact | Stuart Bradley |
| Correspondent | Rita King MethodSense, Inc. 1 Copley Parkway, Suite 410 Morrisville, NC 27560 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-04-15 |