510(k) clearances

MULTIX Impact; MULTIX Impact C

Siemens Medical Solutions USA, Inc. · Radiology

K260488Substantially EquivalentTraditionalKPR
Open FDA's page for this record
Third party flag
N
City
Malvern
Advisory committee description
Radiology
Address 1
40 Liberty Blvd.
Statement or summary
Summary
Product code
KPR
Zip code
19355
Applicant
Siemens Medical Solutions USA, Inc.
Decision date
2026-08-31
Decision code
SESE
Country code
US
Device name
MULTIX Impact; MULTIX Impact C
Advisory committee
RA
Contact
AnnTina Walker
K number
K260488
State
PA
Date received
2026-02-13
Review advisory committee
RA
Postal code
19355
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, X-Ray, Stationary
Medical specialty description
Radiology
Regulation number
892.1680
Device class
2
Registration number
3009134655, 3005778458, 3009001657, 3005172103, 3005810333, 2126677, 3015276088, 3012569470, 3014209556, 3013679558, 9616014, 1450503, 3023190435, 3004485675, 3003768277, 3032116890, 3008364043, 3003768251, 3008496839, 3004077520, 3035950510, 3014293172, 3030089787, 8030233, 3000126629, 3042864600, 3004756607, 3006051164, 2243057, 3006551157, 1064396, 2433615, 3009077524, 3004989804, 3011825597, 3033525986, 3011416394, 3009529630, 3008284470, 3006165260 +43 more
FEI number
1000114111, 3002143662, 3009134655, 3005778458, 3009001657, 3005172103, 3005810333, 3002675731, 2126677, 3015276088, 3012569470, 3014209556, 3013679558, 1450503, 3023190435, 3004485675, 3032116890, 3008364043, 3003768251, 3008496839, 3004077520, 3035950510, 3014293172, 3030089787, 3000126629, 3042864600, 3004756607, 3006051164, 2243057, 3006551157, 3003377038, 2433615, 3009077524, 3004989804, 3011825597, 3033525986, 3011416394, 3009529630, 3002495042, 3008284470 +43 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.