Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tomotherapy Incorporated — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
87 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | Tomotherapy Incorporated | 2011-12-22 | 87 | 0 |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | Tomotherapy Incorporated | 2011-10-07 | 44 | 0 |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | Tomotherapy Incorporated | 2008-08-25 | 42 | 6 |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | Tomotherapy Incorporated | 2006-04-19 | 16 | 4 |
| K042739 | HI-ART SYSTEM | Tomotherapy Incorporated | 2004-11-03 | 30 | 0 |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | Tomotherapy Incorporated | 2003-11-12 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda