510(k) clearances

LVivo IQS

Dia Imaging Analysis, Ltd. · Radiology

K240769Substantially EquivalentSpecialQIH
Open FDA's page for this record
Third party flag
N
City
Beer-Sheva
Advisory committee description
Radiology
Address 1
Haenergia St. 77
Statement or summary
Summary
Product code
QIH
Zip code
8470912
Applicant
Dia Imaging Analysis, Ltd.
Decision date
2024-05-24
Decision code
SESE
Country code
IL
Device name
LVivo IQS
Advisory committee
RA
Contact
Michal Yaacobi
K number
K240769
Date received
2024-03-21
Review advisory committee
RA
Postal code
8470912
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3036502204, 3005403518, 1000432246, 9710090, 3018094310, 3028006458, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3010703925, 3008837339, 3003768277, 3018064242, 3044776706, 3015612252, 3010656400, 3019541896, 9680269, 3042248552, 3003899230, 3014310698, 3018302800, 1644408, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3016965352, 3002808157, 3004141078, 3016585383, 3020703662, 3006209933, 3019878658, 3008284470 +201 more
FEI number
3036502204, 3005403518, 1000432246, 3018094310, 3028006458, 3003405980, 3003310366, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3003309342, 3008837339, 3010703925, 3018064242, 3044776706, 3015612252, 3003408255, 3019541896, 3010656400, 3003899230, 3042248552, 3014310698, 3018302800, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3003377038, 3016965352, 3002808157, 3016585383, 3004141078, 3002808529, 3002808382, 3020703662 +201 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.