510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hitachi High-Tech Corp., Kashiwanoha

KASHIWA-SHI Chiba, JP

HITACHI HIGH-TECH CORP., KASHIWANOHA appears in FDA device records in KASHIWA-SHI Chiba, JP. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Hitachi High-Tech Corp., Kashiwanoha carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Hitachi High-Tech Corp., Kashiwanoha between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hitachi High-Tech Corp., Kashiwanoha, by decision year
YearClearances
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232032PROBEAT-FRLHNSubstantially Equivalent
K220883Small Field ApplicatorLHNSubstantially Equivalent

Registered establishments

FDA registered establishments for Hitachi High-Tech Corp., Kashiwanoha, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10001622061000162206HITACHI HIGH-TECH CORP., KASHIWANOHA226-44-141-1, WAKASHIBA, KASHIWA-SHI Chiba 277-0871 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1430-2026Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRSoftware anomaly in the patient positioning system may result in positional discrepancy.Class IIOpen, Classified
Z-1429-2026Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRSoftware anomaly in the patient positioning system may result in positional discrepancy.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain