510(k) K193381
K193381 is an FDA 510(k) premarket notification submitted by Lifeline Software, Inc. for the device "RadCalc Software". The FDA issued a decision of Substantially Equivalent on Dec 31, 2019. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Lifeline Software, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 31, 2019
- Date Received
- Dec 5, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)