The following data is part of a premarket notification filed by Amcad Biomed Corporation with the FDA for Amcad-ut Detection 2.2.
| Device ID | K180006 |
| 510k Number | K180006 |
| Device Name: | AmCAD-UT Detection 2.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | AmCad BioMed Corporation FL. 5-2, No. 167, Fu Hsing N. RD. Taipei, TW 105 |
| Contact | Jack Yang |
| Correspondent | Chiu S. Lin Lin & Associates, LLC 5614 Johnson Avenue Bethesda, MD 20817 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719875621130 | K180006 | 000 |