The following data is part of a premarket notification filed by Amcad Biomed Corporation with the FDA for Amcad-uv.
| Device ID | K170069 |
| 510k Number | K170069 |
| Device Name: | AmCAD-UV |
| Classification | System, Image Processing, Radiological |
| Applicant | AmCad BioMed Corporation FL.3, NO. 167, Fu Hsing N. RD. Taipei, TW 105 |
| Contact | Jack Yang |
| Correspondent | Chiu S. Lin Lin & Associates, LLC 9223 Cambridge Manor Court Potomac, MD 20854 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-04-26 |
| Summary: | summary |