The following data is part of a premarket notification filed by Radlogics, Inc. with the FDA for Alphapoint Imaging Software.
| Device ID | K120161 |
| 510k Number | K120161 |
| Device Name: | ALPHAPOINT IMAGING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | RADLOGICS, INC. 201 LA CANADA COURT Los Gatos, CA 95023 |
| Contact | Moshe Becker |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-04-13 |
| Summary: | summary |