PROBEAT-FR
K-Number: K232032 · 2024-01-12
Decision Date2024-01-12
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PROBEAT-FR is a medical device manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2024-01-12 under approval number K232032. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PROBEAT-FR?
PROBEAT-FR is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K232032.
When was PROBEAT-FR approved by the FDA?
PROBEAT-FR received FDA 510(k) clearance on 2024-01-12, under approval number K232032.
What company makes PROBEAT-FR?
PROBEAT-FR is manufactured by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha.
What is the FDA product code for PROBEAT-FR?
The FDA product code for PROBEAT-FR is LHN.
Other Devices by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.