The following data is part of a premarket notification filed by Amcad Biomed Corporation with the FDA for Amcad-ut.
| Device ID | K203555 |
| 510k Number | K203555 |
| Device Name: | AmCAD-UT |
| Classification | Automated Radiological Image Processing Software |
| Applicant | AmCad BioMed Corporation FL. 5-2, No.167, Fu Hsing N. RD. Taipei, TW 105 |
| Contact | Nathan Liu |
| Correspondent | Nathan Liu AmCad BioMed Corporation FL.5-2, NO.167, Fu Hsing N. RD. Taipei 105, TW |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-09-08 |