Medical Intelligence Medizintechnik GmbH: FDA clearances and approvals
Medical Intelligence Medizintechnik GmbH has 8 FDA 510(k) clearances (first 2002, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time: 56 days. openFDA lists 1 product recall by a recalling firm named Medical Intelligence Medizintechnik GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 86 |
| 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| JAI | Couch, Radiation Therapy, Powered | 3 | 3 |
Review panels
- Radiology (8)
Most recent Medical Intelligence Medizintechnik GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143485 | iGuide 2.1 | IYE | 2015-03-04 | 86 |
| K121530 | BODYFIX SYSTEM | IYE | 2012-06-20 | 27 |
| K112210 | FRAXION | IYE | 2011-11-22 | 113 |
| K072898 | HEXAPOD EVO RT COUCH TOP | JAI | 2007-10-25 | 14 |
| K071870 | HEXAPOD RT COUCH TOP | JAI | 2007-07-08 | 2 |
| K041448 | HEXAPOD RT COUCHTOP | JAI | 2004-06-16 | 15 |
| K030439 | HEADFIX | IYE | 2003-05-08 | 86 |
| K013391 | BODYFIX | IYE | 2002-01-11 | 88 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-07-18.
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 Medical Intelligence Medizintechnik GmbH have?
Medical Intelligence Medizintechnik GmbH has 8 FDA 510(k) clearances (first 2002, latest 2015), across 2 product codes in 1 review panel.
How long does FDA take to clear Medical Intelligence Medizintechnik GmbH's 510(k)s?
The median time from FDA receipt to decision across Medical Intelligence Medizintechnik GmbH's cleared 510(k)s is 56 days.
What devices does Medical Intelligence Medizintechnik GmbH make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 5); JAI (Couch, Radiation Therapy, Powered, 3).
Has Medical Intelligence Medizintechnik GmbH had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Medical Intelligence Medizintechnik GmbH; the most recent began 2019-07-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Medical Intelligence Medizintechnik GmbH clearances with predicates and recalls
- Run predicate analysis for product code IYE, Medical Intelligence Medizintechnik GmbH'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.