Accuray Incorporated: FDA filings under this applicant name

FDA lists 31 510(k) clearances under 2 spellings of the applicant name “Accuray Incorporated” (first 1999, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 58 days, against 113 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Accuray Incorporated took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.

Top product codes

Review panels

• Radiology (31)

Most recent Accuray Incorporated 510(k) clearances

21 earlier clearances. See the full list in Caduvo.

Recalls

41 product recalls in 34 recall events; 4 initiated in the last five years. Most recent: 2026-06-16.

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.

SEC filings

ACCURAY INC (ARAY): EDGAR filings, CIK 1138723. An SEC registrant with the same name, matched by name only.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Accuray Incorporated (21)
• Accuray, Inc. (10)

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.

• Accuray Incorportaed (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Accuray Incorporated?

FDA lists 31 510(k) clearances under 2 spellings of the applicant name “Accuray Incorporated” (first 1999, latest 2023), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Accuray Incorporated?

The median time from FDA receipt to decision across 510(k)s cleared under the name Accuray Incorporated is 58 days. Since 2017: 58 days, versus 113 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Accuray Incorporated?

The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 19); MUJ (System, Planning, Radiation Therapy Treatment, 9); IWB (System, Radiation Therapy, Radionuclide, 2).

Next steps

• See all 31 Accuray Incorporated clearances with predicates and recalls
• Run predicate analysis for product code IYE, Accuray Incorporated'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 (spelling variants such as punctuation and legal suffixes combined); 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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