Tomotherapy Incorporated: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tomotherapy Incorporated” (first 2003, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 36 days. 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 4 | 4 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
Review panels
- Radiology (6)
Most recent Tomotherapy Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | MUJ | 2011-12-22 | 87 |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | MUJ | 2011-10-07 | 44 |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | MUJ | 2008-08-25 | 42 |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | IYE | 2006-04-19 | 16 |
| K042739 | HI-ART SYSTEM | MUJ | 2004-11-03 | 30 |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | IYE | 2003-11-12 | 23 |
Recalls
12 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2014-11-21.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tomotherapy Incorporated?
FDA lists 6 510(k) clearances under the applicant name “Tomotherapy Incorporated” (first 2003, latest 2011), across 2 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 Tomotherapy Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tomotherapy Incorporated is 36 days.
Which FDA product codes appear under Tomotherapy Incorporated?
The most frequent FDA product codes under this applicant name are MUJ (System, Planning, Radiation Therapy Treatment, 4); IYE (Accelerator, Linear, Medical, 2).
Next steps
- See all 6 Tomotherapy Incorporated clearances with predicates and recalls
- Run predicate analysis for product code MUJ, Tomotherapy 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, 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.