The following data is part of a premarket notification filed by Precisionos Technology Inc. with the FDA for Invisionos.
| Device ID | K210344 |
| 510k Number | K210344 |
| Device Name: | InVisionOS |
| Classification | System, Image Processing, Radiological |
| Applicant | PrecisionOS Technology Inc. 500-319 West Hastings Street Vancouver, CA V6b 1h6 |
| Contact | Danny Goel |
| Correspondent | Danny Goel PrecisionOS Technology Inc. 500-319 West Hastings Street Vancouver, CA V6b 1h6 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-05 |
| Decision Date | 2021-11-10 |