The following data is part of a premarket notification filed by Perception Vision Medical Technologies Ltd.co. with the FDA for Pvmed Contouring Software.
| Device ID | K210916 |
| 510k Number | K210916 |
| Device Name: | PVmed Contouring Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Perception Vision Medical Technologies LTD.CO. Room 306, First Phase Office Building, No. 12 Yuyan Road, Huangpu District Guangzhou, CN 510530 |
| Contact | Chuanji Huang |
| Correspondent | Chuanji Huang Perception Vision Medical Technologies LTD.CO. Room 306, First Phase Office Building, No. 12 Yuyan Road, Huangpu District Guangzhou, CN 510530 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-12-03 |