The following data is part of a premarket notification filed by Lifeline Software, Inc. with the FDA for Radcalc, Model V.4.0.
| Device ID | K010464 |
| 510k Number | K010464 |
| Device Name: | RADCALC, MODEL V.4.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | LIFELINE SOFTWARE, INC. 403 MOCKINGBIRD LN. Tyler, TX 75701 -3053 |
| Contact | Craig A Laughton |
| Correspondent | Craig A Laughton LIFELINE SOFTWARE, INC. 403 MOCKINGBIRD LN. Tyler, TX 75701 -3053 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-16 |
| Decision Date | 2001-05-17 |