510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa

KASHIWA-SHI Chiba, JP

FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa appears in FDA device records in KASHIWA-SHI Chiba, JP. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

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

FDA records under these names

1 name

FDA records resolved to FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa 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., Medical System Operations Groupenforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30184233373018423337FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa2-1, SHINTOYOFUTA, KASHIWA-SHI Chiba 277-0804 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-1585-2018MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.Class IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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