Data / Medical devices / United States / Lifeline Software, Inc.
Lifeline Software, Inc.: FDA-registered device maker in Tyler, TX, United States, 1 510(k) clearance
Lifeline Software, Inc. is registered with the FDA (registration 1651102) in Tyler, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 31, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1651102
- FEI number
- 3002802883
- Address
- 102 N College Ave Ste 1014, Tyler, TX, United States, 75702
- Owner or operator
- LIFELINE SOFTWARE, INC. (9036737)
- Roles
- Manufacturer
- First device listed
- February 7, 2020
- Registered through
- 2027
- Brand names listed
- RadCalc Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 31, 2019 | K193381 | RadCalc Software | MUJ | Substantially Equivalent | Lifeline Software, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated December 31, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.