The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Ramsoft Pacs, Model 3.0.
| Device ID | K031562 |
| 510k Number | K031562 |
| Device Name: | RAMSOFT PACS, MODEL 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | RAMSOFT, INC. 215-16 FOUR SEASONS PLACE Toronto, On, CA M9b 6e5 |
| Contact | Lucian Popescu |
| Correspondent | Lucian Popescu RAMSOFT, INC. 215-16 FOUR SEASONS PLACE Toronto, On, CA M9b 6e5 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-19 |
| Decision Date | 2003-08-11 |
| Summary: | summary |