The following data is part of a premarket notification filed by Anatomage Inc. with the FDA for Invivo Web Viewer.
| Device ID | K181926 |
| 510k Number | K181926 |
| Device Name: | InVivo Web Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Anatomage Inc. 303 N. Almaden Blvd. Suite 700 San Jose, CA 95110 |
| Contact | Changxin Xu |
| Correspondent | Changxin Xu Anatomage Inc. 303 Almaden Blvd. Suite 700 San Jose, CA 95110 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2018-09-21 |
| Summary: | summary |