The following data is part of a premarket notification filed by Acroviz Inc. with the FDA for Acrodti Visualizer.
| Device ID | K201948 |
| 510k Number | K201948 |
| Device Name: | AcroDTI Visualizer |
| Classification | System, Image Processing, Radiological |
| Applicant | AcroViz Inc. Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd., Zhongzhcng Dist, Taipei, TW 10050 |
| Contact | Yung-chin Hsu |
| Correspondent | Yung-chin Hsu AcroViz Inc. Rm. 6. HF, No. 152, Sec. 1. Zhongxiao E. Rd., Zhongzhcng Dist, Taipei, TW 10050 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-09-09 |