The following data is part of a premarket notification filed by Lifeline Software, Inc. with the FDA for Radcalc Software.
| Device ID | K193381 |
| 510k Number | K193381 |
| Device Name: | RadCalc Software |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | LifeLine Software, Inc. 3304 S Broadway Ave, Suite 200 Tyler, TX 75701 |
| Contact | Craig Laughton |
| Correspondent | Craig Laughton LifeLine Software, Inc. 3304 S Broadway Ave, Suite 200 Tyler, TX 75701 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-05 |
| Decision Date | 2019-12-31 |