Imt America, Inc.: FDA clearances and approvals
Imt America, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1990), across 3 product codes in 1 review panel. Median 510(k) review time: 111 days.
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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | 2 | 2 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 2 | 2 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Review panels
- Radiology (5)
Most recent Imt America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903921 | MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE | IZZ | 1990-12-04 | 102 |
| K901654 | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE | IXR | 1990-11-23 | 227 |
| K903422 | MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE | IXR | 1990-09-04 | 35 |
| K900193 | MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT | OXO | 1990-05-09 | 113 |
| K900194 | MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | OXO | 1990-05-07 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Imt America, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Imt America, Inc. have?
Imt America, Inc. has 5 FDA 510(k) clearances (first 1990, latest 1990), across 3 product codes in 1 review panel.
How long does FDA take to clear Imt America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Imt America, Inc.'s cleared 510(k)s is 111 days.
What devices does Imt America, Inc. make?
Its most frequent FDA product codes are IXR (Table, Radiographic, Tilting, 2); OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile, 2); IZZ (Table, Radiographic, Non-Tilting, Powered, 1).
Has Imt America, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Imt America, Inc. Related entities may recall under other names.
Next steps
- See all 5 Imt America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IXR, Imt America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.