Cleared Traditional

Sample Imaging for Senographe Pristina

K190809 · Ge Healthcare · Radiology

Jul 2019

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K190809 is an FDA 510(k) clearance for the Sample Imaging for Senographe Pristina, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Ge Healthcare (Buc, FR). The FDA issued a Cleared decision on July 29, 2019, 122 days after receiving the submission on March 29, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number	K190809 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2019
Decision Date	July 29, 2019
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF