Senographe Pristina

Full Field Digital, System, X-ray, Mammographic

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Senographe Pristina.

Pre-market Notification Details

• 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

NIH GUDID Devices

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
00195278527929	K162268	000
00195278527936	K162268	000
00195278527943	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
00195278719812	K162268	000