510(k) K181676
- Device
- Mini Ridge Filter And Auxiliary Functions For PROBEAT-V
- Applicant
- Hitachi Ltd. Healthcare Hitachi Works
- 510(k) number
- K181676
- Product code
- LHN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-15
- Date received
- 2018-06-25
- Regulation
- 892.5050
- Classification name
- System, Radiation Therapy, Charged-particle, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tomoyuki Seino
- Address
- 3-1-1, Saiwai-Cho Hitachi JP 317-8511 317-8511
FDA Registration Numbers#
- 8031557
- 3009754495
- 1000162206
- 3010726836
- 3005374502
- 1721113
- 3003993895
- 9681124
- 3004977335
- 9614952
- 3010658895
- 8043933
- 2032229
- 3015232217
- 3007087027
- 3042022819
- 1038814
- 2247992
- 3000256071
- 3008317830
- 9613183
- 3015178562
- 2916710
- 3016872563
- 1062572
- 2953704
Source Documents#
Other 510(k) Records For Product Code LHN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026-04-23 |
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2026-03-25 |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. | 2025-09-12 |
| K243900 | eMotus Respiratory Motion Management System | Empnia, Inc. | 2025-06-27 |
| K242418 | P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. | 2025-05-12 |
| K232032 | PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 |
| K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023-10-06 |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | 2023-03-20 |
| K220883 | Small Field Applicator | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2022-12-15 |
| K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022-12-01 |
| K201798 | myQA iON | Iba Dosimetry GmbH | 2020-07-17 |
| K201042 | PROBEAT-CR | Hitachi , Ltd. | 2020-07-13 |
| K200282 | Orfit Aerial Couchtop | Orfit Industries NV | 2020-04-08 |
| K191821 | Blue Phantom PT | Iba Dosimetry GmbH | 2020-01-23 |
| K191521 | Radiance 330 Proton Beam Therapy System | Protom International Holding Corporation | 2019-09-27 |
Legacy Summary#
summary
FDA Review#
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