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510(k) clearances

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · Radiology

K261933Substantially EquivalentTraditionalIYN
Open FDA's page for this record
Third party flag
N
City
Waukesha
Advisory committee description
Radiology
Address 1
3200 N Grandview Blvd.
Statement or summary
Summary
Product code
IYN
Zip code
53188
Applicant
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
Decision date
2026-10-02
Decision code
SESE
Country code
US
Device name
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Advisory committee
RA
Contact
Bryan Behn
K number
K261933
State
WI
Date received
2026-06-09
Review advisory committee
RA
Postal code
53188
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty description
Radiology
Regulation number
892.1550
Device class
2
Registration number
3003412859, 3016436764, 8043933, 3029916061, 3007562060, 3031158, 3010398867, 9710602, 3010041511, 3001722928, 3009247326, 3021970996, 3014302721, 1826555, 3026405201, 3006161756, 3012747207, 3008992312, 3004752776, 3021591288, 3010220244, 3010400367, 3007194257, 3007836437, 2518897, 3015997711, 3033527241, 3016696283, 3016854601, 1528028, 1066427, 3007994837, 3010102386, 3003594449, 3008921662, 3009212453, 3019784575, 3008496839, 3012104670, 3012987001 +183 more
FEI number
3003412859, 3016436764, 3029916061, 3007562060, 3010398867, 3003309342, 3010041511, 3001722928, 3009247326, 3021970996, 3014302721, 1826555, 3026405201, 3012747207, 3008992312, 3004752776, 3021591288, 3010220244, 3010400367, 3003208270, 3007194257, 3007836437, 3003589956, 3015997711, 3033527241, 3002808127, 3016696283, 1528028, 3007994837, 3010102386, 3003594449, 3016854601, 3008921662, 3009212453, 3019784575, 3008496839, 3012104670, 3012987001, 1045254, 3009039068 +183 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.