This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for changes to the patient table shape; detector upgrade; new quality control phantom and labeling; x-ray generator upgrade; image storage, display server and command processor upgrade; minor replacements of electrical components.
| Device | KONING BREAST CT (MODEL CBCT 1000) |
| Generic Name | Cross-sectional Mammographic Xray System |
| Applicant | KONING CORPORATION |
| Date Received | 2015-12-28 |
| Decision Date | 2016-10-06 |
| PMA | P130025 |
| Supplement | S002 |
| Product Code | OLQ |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KONING CORPORATION 150 Lucius Gordon Drive suite 112 w Henrietta, NY 14586 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130025 | Original Filing | |
| S003 | 2017-09-05 | Real-time Process |
| S002 | 2015-12-28 | Normal 180 Day Track |
| S001 |