510(k) clearances

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance , Ltd. · Radiology

K260758Substantially EquivalentTraditionalLNH
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Radiology
Address 1
Siemens Mri Center, Gaoxin C. Ave., 2nd, Hi-Tech Industrial
Statement or summary
Summary
Product code
LNH
Zip code
518057
Applicant
Siemens Shenzhen Magnetic Resonance , Ltd.
Decision date
2026-09-01
Decision code
SESE
Country code
CN
Device name
MAGNETOM Free.Max; MAGNETOM Free.Star
Advisory committee
RA
Contact
Li Hai Ting
K number
K260758
Date received
2026-03-09
Review advisory committee
RA
Postal code
518057
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Nuclear Magnetic Resonance Imaging
Medical specialty description
Radiology
Regulation number
892.1000
Device class
2
Registration number
2029299, 1723170, 3008632256, 2432211, 1221108, 3006262888, 3023003446, 3006738448, 3015223550, 3033527281, 3006849754, 3009882464, 3004531751, 9616047, 3017383732, 3016727312, 9617277, 3027339477, 3019595609, 3014232555, 3013679558, 3005517190, 3015425142, 3023385454, 3013695852, 3027325776, 3012761544, 9611343, 3009755250, 2520313, 3002808157, 3013343065, 1650907, 3021593788, 3008355361, 3010398867, 3004526608, 3012439308, 3031503890, 3004977335 +108 more
FEI number
1000143606, 3008632256, 2432211, 1221108, 3006262888, 3023003446, 3006738448, 3015223550, 3033527281, 3006849754, 3009882464, 3002807880, 3004531751, 3017383732, 3016727312, 3027339477, 3019595609, 3014232555, 3013679558, 3003190524, 3005517190, 3015425142, 3023385454, 3013695852, 3002806926, 3027325776, 3012761544, 2520313, 3009755250, 3002808157, 3013343065, 3021593788, 3008355361, 3010398867, 3004526608, 3012439308, 3031503890, 3004977335, 3036666444, 3008447096 +108 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.