The following data is part of a premarket notification filed by Medmind Technology Co., Ltd. with the FDA for Rt-mind-ai.
| Device ID | K213155 |
| 510k Number | K213155 |
| Device Name: | RT-Mind-AI |
| Classification | Radiological Image Processing Software For Radiation Therapy |
| Applicant | MedMind Technology Co., Ltd. A502-503, Techart Plaza, No.30, Xueyuan Road, Haidian District Beijing, CN 100083 |
| Contact | Shaobin Wang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | QKB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2021-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975191150008 | K213155 | 000 |