The following data is part of a premarket notification filed by Brainnow Medical Technology Limited with the FDA for Accubrain.
| Device ID | K202847 |
| 510k Number | K202847 |
| Device Name: | AccuBrain |
| Classification | System, Image Processing, Radiological |
| Applicant | BrainNow Medical Technology Limited Unit 201, 2/F, Lakeside 2, No. 10 Science Park West Avenue, Hong Kong Science Park, Shatin, N.T. Hong Kong, CN 999077 |
| Contact | Junbing Huang |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04897117800007 | K202847 | 000 |