510(k) K192554
K192554 is an FDA 510(k) premarket notification submitted by .Decimal, LLC for the device "decimal3D". The FDA issued a decision of Substantially Equivalent on December 13, 2019. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. .Decimal, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2019
- Date Received
- September 17, 2019
- Clearance Type
- Traditional
- 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