510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MUEClass II

Full Field Digital, System, X-Ray, Mammographic

21 CFR 892.1715 / Radiology
FDA source (opens on fda.gov)

MUE is the FDA product code for Full Field Digital, System, X-Ray, Mammographic, a class II device type, regulated under 21 CFR 892.1715. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and 41 recalls.

Classification record

Product code
MUE
Device name
Full Field Digital, System, X-Ray, Mammographic
Regulation
21 CFR 892.1715
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
56
Ingested recalls
41

Clearances, product code MUE

By decision year
56 clearances under product code MUE with a decision year between 2011 and 2026, 2011 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code MUE by decision year
YearClearances
201110
20124
20137
20141
20151
20161
20178
20182
20192
20204
20214
20223
20231
20241
20253
20264

Applicants with the most clearances

Product code MUE
Applicants holding the most 510(k) clearances under product code MUE
ApplicantClearances
GE Healthcare9
Siemens Medical Solutions USA, Inc.7
FUJIFILM Healthcare Americas Corporation5
Planmed Oy4
DRTECH Corporation3
Philips Digital Mammography Sweden AB3
GE Medical Systems SCS2
General Electric Co.2
Rayence Co., Ltd.2
Vieworks Co., Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order