Koning Corporation: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Koning Corporation”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLQ | Cross-Sectional Mammographic Xray System | 1 | 0 |
Review panels
- Radiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130025 | PMA | KONING BREAST CT (MODEL CBCT1000) | 2015-01-14 |
Recalls
openFDA lists no recalls under a recalling firm named Koning Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Koning Corporation is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05036096: Cone Beam Breast CT for Breast Cancer Screening (Active not recruiting, started 2021-10-30)
- NCT01750320: Koning Breast Computed Tomography Guided Biopsy (Completed, started 2012-08)
- NCT01771497: Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring (Completed, started 2010-07)
- NCT01107860: Cone Beam Computed Tomography for Breast Imaging (Completed, started 2010-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Koning Corporation?
FDA lists 0 510(k) clearances under the applicant name “Koning Corporation”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Koning Corporation?
The most frequent FDA product codes under this applicant name are OLQ (Cross-Sectional Mammographic Xray System, 1).
Next steps
- See all 0 Koning Corporation clearances with predicates and recalls
- Run predicate analysis for product code OLQ, Koning Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.