Pie Medical Imaging BV: FDA clearances and approvals
Pie Medical Imaging BV has 23 FDA 510(k) clearances (first 2001, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time: 106 days. Since 2017 its median was 238 days, against 130 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 2013 | 1 | 42 |
| 2014 | 0 | — |
| 2015 | 1 | 107 |
| 2016 | 4 | 128 |
| 2017 | 0 | — |
| 2018 | 2 | 134 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 290 |
| 2023 | 0 | — |
| 2024 | 2 | 238 |
| 2025 | 1 | 271 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pie Medical Imaging BV's cleared 510(k)s took a median 238 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 18 | 18 |
| IZI | System, X-Ray, Angiographic | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | 1 | 1 |
| QIH | Automated Radiological Image Processing Software | 1 | 1 |
Review panels
- Radiology (22)
- Cardiovascular (1)
Most recent Pie Medical Imaging BV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250330 | 3mensio Workstation | QIH | 2025-11-03 | 271 |
| K232147 | CAAS Workstation | QHA | 2024-04-09 | 265 |
| K232007 | CAAS MR Solutions | LLZ | 2024-02-01 | 210 |
| K212376 | Caas Qardia | LLZ | 2022-05-16 | 290 |
| K181825 | CAAS MR Solutions | LLZ | 2018-12-04 | 148 |
| K180019 | CAAS Workstation | IZI | 2018-05-03 | 121 |
| K162376 | CAAS MR 4D Flow | LLZ | 2016-12-08 | 106 |
| K162112 | CAAS MRV | LLZ | 2016-09-21 | 54 |
| K153736 | 3mensio Workstation | LLZ | 2016-05-27 | 151 |
| K151780 | CAAS Workstation | IZI | 2016-03-11 | 254 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pie Medical Imaging BV.
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 Pie Medical Imaging BV have?
Pie Medical Imaging BV has 23 FDA 510(k) clearances (first 2001, latest 2025), across 5 product codes in 2 review panels.
How long does FDA take to clear Pie Medical Imaging BV's 510(k)s?
The median time from FDA receipt to decision across Pie Medical Imaging BV's cleared 510(k)s is 106 days. Since 2017: 238 days, versus 130 days for all cleared 510(k)s in the same product codes.
What devices does Pie Medical Imaging BV make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 18); IZI (System, X-Ray, Angiographic, 2); DQK (Computer, Diagnostic, Programmable, 1).
Has Pie Medical Imaging BV had device recalls?
openFDA lists no recalls under a recalling firm name matching Pie Medical Imaging BV. Related entities may recall under other names.
Next steps
- See all 23 Pie Medical Imaging BV clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Pie Medical Imaging BV'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.