510(k) K232032
K232032 is an FDA 510(k) premarket notification submitted by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha for the device "PROBEAT-FR". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2024
- Date Received
- July 7, 2023
- Clearance Type
- Traditional
- 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