PROBEAT

System, Radiation Therapy, Charged-particle, Medical

HITACHI, LTD., POWER SYSTEMS GROUP

The following data is part of a premarket notification filed by Hitachi, Ltd., Power Systems Group with the FDA for Probeat.

Pre-market Notification Details

• Device ID: K053280
• 510k Number: K053280
• Device Name: PROBEAT
• Classification: System, Radiation Therapy, Charged-particle, Medical
• Applicant: HITACHI, LTD., POWER SYSTEMS GROUP 555 THIRTEENTH STREET, NW Washington, DC 20004
• Contact: Jonathan Kahan
• Correspondent: Jonathan Kahan; HITACHI, LTD., POWER SYSTEMS GROUP 555 THIRTEENTH STREET, NW Washington, DC 20004
• Product Code: LHN
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-11-23
• Decision Date: 2006-03-09
• Summary: summary