The following data is part of a premarket notification filed by Lin & Associates, Llc. with the FDA for Amcad-ut Detection Model 2.0.
| Device ID | K122536 |
| 510k Number | K122536 |
| Device Name: | AMCAD-UT DETECTION MODEL 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | LIN & ASSOCIATES, LLC. 9223 CAMBRIDGE MANOR COURT Potomac, MD 20854 |
| Contact | Chiu S Lin |
| 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 | 2012-08-20 |
| Decision Date | 2013-10-03 |
| Summary: | summary |