The following data is part of a premarket notification filed by Mckesson Medical Imaging Company with the FDA for Mckesson Radiology Mammography Plus.
| Device ID | K142850 |
| 510k Number | K142850 |
| Device Name: | McKesson Radiology Mammography Plus |
| Classification | System, Image Processing, Radiological |
| Applicant | MCKESSON MEDICAL IMAGING COMPANY 130-10711 CAMBIE ROAD Richmond, B.c., CA V6x 3g5 |
| Contact | Gilbert Wong |
| Correspondent | Paul Sumner MCKESSON TECHNOLOGIES INC. 5995 WINDWARD PARKWAY Alpharetta, GA 30005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262180039 | K142850 | 000 |
| 17540262180022 | K142850 | 000 |
| 17540262180015 | K142850 | 000 |
| 17540262180046 | K142850 | 000 |