Koning Breast CT, KBCT

FDA Premarket Approval P130025 S003

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.

Pre-market Approval Supplement Details

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.

DeviceKoning Breast CT, KBCT
Generic NameCross-sectional Mammographic Xray System
ApplicantKONING CORPORATION
Date Received2017-09-05
Decision Date2017-10-24
PMAP130025
SupplementS003
Product CodeOLQ 
Advisory CommitteeRadiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address KONING CORPORATION 150 Lucius Gordon Drive suite 112 w Henrietta, NY 14586

Supplemental Filings

Supplement NumberDateSupplement Type
P130025Original Filing
S003 2017-09-05 Real-time Process
S002 2015-12-28 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
19764496368300 P130025 004
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