The following data is part of a premarket notification filed by Lifeline Software, Inc. with the FDA for Radcalc Software, Version 6.0.
| Device ID | K090531 |
| 510k Number | K090531 |
| Device Name: | RADCALC SOFTWARE, VERSION 6.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | LIFELINE SOFTWARE, INC. 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Contact | Richard Vincins |
| Correspondent | Richard Vincins LIFELINE SOFTWARE, INC. 1705 S. CAPITAL OF TEXAS HWY. SUITE 500 Austin, TX 78746 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-27 |
| Decision Date | 2009-05-27 |
| Summary: | summary |