K232032 is an FDA 510(k) clearance for the PROBEAT-FR. This device is classified as a System, Radiation Therapy, Charged-particle, Medical (Class II - Special Controls, product code LHN).
Submitted by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (Kashiwa-Shi, JP). The FDA issued a Cleared decision on January 12, 2024, 189 days after receiving the submission on July 7, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K232032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | January 12, 2024 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LHN - System, Radiation Therapy, Charged-particle, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |