Hitachi Medical Corp.: FDA filings under this applicant name

FDA lists 12 510(k) clearances under the applicant name “Hitachi Medical Corp.” (first 1982, latest 2016), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.

510(k) clearances per year

Top product codes

Plus 1 more product codes.

Review panels

• Radiology (10)
• Anesthesiology (1)

Most recent Hitachi Medical Corp. 510(k) clearances

2 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Hitachi Medical Corp..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hitachi Medical Corp. (a text match, not an official crosswalk):

• C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
• C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
• C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
• C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
• C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Hitachi Medical Systems America, Inc. (100 510(k)s)
• Hitachi Medical Corp. of America (32 510(k)s)
• Hitachi Healthcare Americas (17 510(k)s)
• Hitachi Chemical Diagnostics, Inc. (16 510(k)s)
• Hitachi , Ltd. (8 510(k)s)
• Hitachi Aloka Medical, Ltd. (6 510(k)s)
• Hitachi, Ltd., Health Care Company (4 510(k)s)
• Hitachi Aloka Medical America, Inc. (3 510(k)s)
• Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical (3 510(k)s)
• Hitachi, Ltd., Power Systems Group (2 510(k)s)
• Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (2 510(k)s)
• Hitachi Sales Corporation of America (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Hitachi Medical Corp.?

FDA lists 12 510(k) clearances under the applicant name “Hitachi Medical Corp.” (first 1982, latest 2016), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Hitachi Medical Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Hitachi Medical Corp. is 86 days.

Which FDA product codes appear under Hitachi Medical Corp.?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).

Next steps

• See all 12 Hitachi Medical Corp. clearances with predicates and recalls
• Run predicate analysis for product code IYN, Hitachi Medical Corp.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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