DeviceClearance

Product code MUE— Radiology

Senographe Pristina

Classification name
Full Field Digital, System, X-Ray, Mammographic
Device class
Class 2
Regulation
21 CFR 892.1715
Advisory panel
Radiology
Total cleared
56
First cleared
Most recent

Market context for product code MUE

FDA has cleared 56 devices under product code MUE between 2011 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MUE

Adverse events under product code MUE

product code MUE
Death
5
Other
1
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MUE

Data sourced from openFDA. This site is unofficial and independent of the FDA.