The following data is part of a premarket notification filed by Mckesson Medical Imaging Company with the FDA for Mckesson Radiology.
| Device ID | K140909 |
| 510k Number | K140909 |
| Device Name: | MCKESSON RADIOLOGY |
| Classification | System, Image Processing, Radiological |
| Applicant | MCKESSON MEDICAL IMAGING COMPANY 5995 WINWARD PARKWAY Alpharetta, GA 30005 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner MCKESSON MEDICAL IMAGING COMPANY 5995 WINWARD 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 | 2014-04-09 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80010939020044 | K140909 | 000 |
| 80010939020020 | K140909 | 000 |
| 80010939020013 | K140909 | 000 |
| 17540262030013 | K140909 | 000 |
| 17540262020021 | K140909 | 000 |
| 17540262030020 | K140909 | 000 |
| 17540262030037 | K140909 | 000 |
| 17540262030044 | K140909 | 000 |
| 17540262030051 | K140909 | 000 |