510(k) clearances

Accuro XV

Rivanna Medical, Inc. · Radiology

K262093Substantially EquivalentTraditionalIYO
Open FDA's page for this record
Third party flag
N
City
Charlottesville
Advisory committee description
Radiology
Address 1
2400 Hunters Way
Statement or summary
Summary
Product code
IYO
Zip code
22911
Applicant
Rivanna Medical, Inc.
Decision date
2026-10-20
Decision code
SESE
Country code
US
Device name
Accuro XV
Advisory committee
RA
Contact
F. William Mauldin
K number
K262093
State
VA
Date received
2026-06-22
Review advisory committee
RA
Postal code
22911
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Imaging, Pulsed Echo, Ultrasonic
Medical specialty description
Radiology
Regulation number
892.1560
Device class
2
Registration number
3005406110, 3008487708, 3008729547, 2518897, 3003589956, 3017955833, 2531475, 3008506949, 3010663777, 9617592, 2521877, 3009435759, 2025099, 3013535906, 3018884581, 3010390468, 3026047529, 3002808148, 3009156722, 9680579, 3027501622, 3006786907, 3010400367, 3011692238, 9615439, 3012198618, 3011278898, 3007740628, 3008548323, 9610816, 3011162972, 3011050570, 3003971136, 3013844297, 3003647374, 8020021, 3007015148, 3007994837, 3031564213, 3007603826 +316 more
FEI number
3005406110, 3008487708, 3008729547, 3003589956, 3017955833, 3003408255, 3002808127, 3008506949, 3010663777, 2521877, 3009435759, 3013535906, 3018884581, 3010390468, 3026047529, 3002808148, 3009156722, 3027501622, 3006786907, 3010400367, 3011692238, 3012198618, 3011278898, 3002807138, 3007740628, 3008548323, 3002619595, 3011162972, 3003861317, 3011050570, 3003971136, 3013844297, 3003647374, 3007015148, 3007994837, 3031564213, 3007603826, 3025786376, 3008223664, 3003040625 +315 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.