510(k) K181789
K181789 is an FDA 510(k) premarket notification submitted by Medcom GmbH for the device "VeriSuite". The FDA issued a decision of Substantially Equivalent on September 21, 2018. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Medcom GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2018
- Date Received
- July 5, 2018
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Charged-Particle, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type