← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

LNH — System, Nuclear Magnetic Resonance Imaging

DEVICE CLASS
Class II
REGULATION
21 CFR 892.1000
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
45
510(K)/PMA CLEARANCES
510k: 45
0
RECALL ENTRIES

Recent clearances

K260113Shanghai United Imaging Healthcare Co., Ltd. · 510k2026-05-22
K253862Fujifilm Corporation · 510k2026-04-06
K253625Canon Medical Systems Corporation · 510k2026-03-27
K260746Esaote, S.p.A. · 510k2026-03-27
K251937Nordicneurolab AS · 510k2026-03-20
K254277Aspect Imaging, Ltd. · 510k2026-03-13
K253413Perspectum, Ltd. · 510k2026-03-09
K251901Esaote, S.p.A. · 510k2026-03-05

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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