Canon Medical Systems: FDA 510(k) clearances across all its applicant names

FDA lists 435 510(k) clearances, 0 PMA and 0 De Novo decisions across the 9 applicant names Caduvo groups under Canon Medical Systems, first 1977, latest 2026. Median 510(k) review time across these names: 73 days. Since 2017 the median was 84 days, against 115 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 9 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.

Top product codes

Plus 24 more product codes.

Review panels

• Radiology (426)
• Cardiovascular (5)
• General Hospital (3)
• Neurology (1)

Most recent Canon Medical Systems 510(k) clearances

425 earlier clearances. See the full list in Caduvo.

Recalls

10 product recalls in 10 recall events under these names; 0 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Canon acquired Toshiba Medical Systems in December 2016 (renamed Canon Medical Systems 2018). Includes Toshiba-era filings. Vital Images (Toshiba 2011) included.

Sources

• https://en.wikipedia.org/wiki/Canon_Medical_Systems_Corporation

Frequently asked questions

How many FDA 510(k) clearances are listed across Canon Medical Systems's applicant names?

FDA lists 435 510(k) clearances, 0 PMA and 0 De Novo decisions across the 9 applicant names Caduvo groups under Canon Medical Systems, first 1977, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Canon Medical Systems file under?

The names with the most 510(k) clearances in this group are Toshiba America Medical Systems, In.C (146); Canon Medical Systems Corporation (97); Toshibamedical Systems Corporation (80); Toshiba Medical Systems (54); Vital Images, Inc. (41). The full list of 9 names is on this page.

How long does FDA take to clear Canon Medical Systems 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 73 days. Since 2017 the median was 84 days, against 115 days for all cleared 510(k)s in the same product codes.

Does the Canon Medical Systems count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 435 Canon Medical Systems clearances with predicates and recalls
• Run predicate analysis for product code JAK, Canon Medical Systems's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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