The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Ultrapro Model 98.
| Device ID | K982563 |
| 510k Number | K982563 |
| Device Name: | ULTRAPRO MODEL 98 |
| Classification | System, Image Processing, Radiological |
| Applicant | RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario, CA M9w 6s6 |
| Contact | Naganatha S Ramanathan |
| Correspondent | Naganatha S Ramanathan RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario, CA M9w 6s6 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-23 |
| Decision Date | 1998-10-06 |
| Summary: | summary |