← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MUE — Full Field Digital, System, X-Ray, Mammographic

DEVICE CLASS
Class II
REGULATION
21 CFR 892.1715
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K253678Siemens Medical Solutions USA, Inc. · 510k2026-06-18
K254092Vieworks Co., Ltd. · 510k2026-05-28
K260087GE Medical Systems SCS · 510k2026-03-24
K243420Genoray Co., Ltd. · 510k2025-07-17
K243849Rayence Co., Ltd. · 510k2025-03-12
K241113Vieworks Co., Ltd. · 510k2025-01-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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