The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Senographe Pristina.
Device ID | K162268 |
510k Number | K162268 |
Device Name: | Senographe Pristina |
Classification | Full Field Digital, System, X-ray, Mammographic |
Applicant | GE HEALTHCARE 283 RUE DE LA MINIERE Buc, FR 78530 |
Contact | Gregory Pessato |
Correspondent | Gregory Pessato GE HEALTHCARE 283 RUE DE LA MINIERE Buc, FR 78530 |
Product Code | MUE |
CFR Regulation Number | 892.1715 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-12 |
Decision Date | 2016-11-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682145879 | K162268 | 000 |
00195278527912 | K162268 | 000 |
00195278527882 | K162268 | 000 |
00195278527950 | K162268 | 000 |
00195278527899 | K162268 | 000 |
00840682146845 | K162268 | 000 |
00195278560049 | K162268 | 000 |
00195278716026 | K162268 | 000 |
00195278665379 | K162268 | 000 |
00195278661999 | K162268 | 000 |
00195278655141 | K162268 | 000 |
00195278711229 | K162268 | 000 |
00195278795724 | K162268 | 000 |
00195278719812 | K162268 | 000 |
00195278527929 | K162268 | 000 |
00195278527936 | K162268 | 000 |
00840682143516 | K162268 | 000 |
00840682142052 | K162268 | 000 |
00840682138826 | K162268 | 000 |
00840682138802 | K162268 | 000 |
00840682125802 | K162268 | 000 |
00840682122603 | K162268 | 000 |
00840682118460 | K162268 | 000 |
00195278330390 | K162268 | 000 |
00195278223937 | K162268 | 000 |
00195278276971 | K162268 | 000 |
00195278022745 | K162268 | 000 |
00195278527905 | K162268 | 000 |
00195278527943 | K162268 | 000 |
00195278866899 | K162268 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENOGRAPHE PRISTINA 86652853 5261610 Live/Registered |
General Electric Company 2015-06-05 |