510(k) clearances

AVIEW CAC

Coreline Soft Co., Ltd. · Radiology

K243696Substantially EquivalentSpecialQIH
Open FDA's page for this record
Third party flag
N
City
Seoul
Advisory committee description
Radiology
Address 1
12, Donggyo-Ro 19-Gil, Mapo-Gu
Statement or summary
Summary
Product code
QIH
Zip code
04001
Applicant
Coreline Soft Co., Ltd.
Decision date
2025-02-14
Decision code
SESE
Country code
KR
Device name
AVIEW CAC
Advisory committee
RA
Contact
Hyeyi Park
K number
K243696
Date received
2024-11-29
Review advisory committee
RA
Postal code
04001
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.