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 input power requirements to 210-240 vac, 30 amp service and software changes associated with an added light switch, camera and touch screen interface.
| Device | Koning Breast CT, KBCT |
| Generic Name | Cross-sectional Mammographic Xray System |
| Applicant | KONING CORPORATION |
| Date Received | 2017-09-05 |
| Decision Date | 2017-10-24 |
| PMA | P130025 |
| Supplement | S003 |
| Product Code | OLQ |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| 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 |