Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imt America, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
227 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903921 | MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE | Imt America, Inc. | 1990-12-04 | 102 | 0 |
| K901654 | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE | Imt America, Inc. | 1990-11-23 | 227 | 0 |
| K903422 | MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE | Imt America, Inc. | 1990-09-04 | 35 | 0 |
| K900193 | MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT | Imt America, Inc. | 1990-05-09 | 113 | 0 |
| K900194 | MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Imt America, Inc. | 1990-05-07 | 111 | 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