510(k) clearances

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC · Radiology

K262311Substantially EquivalentSpecialIYN
Open FDA's page for this record
Third party flag
N
City
Bothell
Advisory committee description
Radiology
Address 1
22100 Bothell Everett Hwy.
Statement or summary
Summary
Product code
IYN
Zip code
98021
Applicant
Philips Ultrasound, LLC
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
Alturion Series Diagnostic Ultrasound System
Advisory committee
RA
Contact
Irma Sandoval-Watt
K number
K262311
State
WA
Date received
2026-07-08
Review advisory committee
RA
Postal code
98021
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty description
Radiology
Regulation number
892.1550
Device class
2
Registration number
8043836, 2939830, 3031823165, 3003774756, 3010760216, 1000601180, 3016076141, 3027501622, 3004753388, 3006680097, 3005334138, 3033527283, 3003594449, 2029275, 3010041511, 9710090, 3014755924, 9617277, 3010952312, 3014574557, 3033508292, 3019216, 1062741, 1416980, 3012981490, 1643817, 3021591288, 3007836437, 3042228064, 3033858858, 3003600763, 3002619337, 3012761544, 3012747207, 3010082909, 3025786376, 3010398867, 3031397684, 3003589956, 3003971136 +182 more
FEI number
3031823165, 3003774756, 3010760216, 1000601180, 3016076141, 3027501622, 3004753388, 3006680097, 3005334138, 3003309342, 3033527283, 3002087856, 3010289997, 3003594449, 3010041511, 3000302153, 3002827704, 3014755924, 3010952312, 3014574557, 3003190524, 3033508292, 3019216, 1416980, 3012981490, 1643817, 3021591288, 3007836437, 3042228064, 3000957797, 3033858858, 3003600763, 3002619337, 3002626007, 3012761544, 3012747207, 3010082909, 3025786376, 3010398867, 3031397684 +182 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.