510(k) clearances

OncoStudio (OS-01)

Oncosoft. Co., Ltd. · Radiology

K242994Substantially EquivalentTraditionalQKB
Open FDA's page for this record
Third party flag
N
City
Seoul
Advisory committee description
Radiology
Address 1
37, Myeongmul-Gil, Seodaemun-Gu
Statement or summary
Summary
Product code
QKB
Zip code
03776
Applicant
Oncosoft. Co., Ltd.
Decision date
2025-02-24
Decision code
SESE
Country code
KR
Device name
OncoStudio (OS-01)
Advisory committee
RA
Contact
Boram Kim
K number
K242994
Date received
2024-09-26
Review advisory committee
RA
Postal code
03776
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Radiological Image Processing Software For Radiation Therapy
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3021032044, 3019834893, 3022719374, 3015169361, 3007545404, 3002808157, 3016686005, 3017927156, 8043933, 3022745617, 3013410552, 3004363352, 3031194398, 3015232217, 3036758982, 3007120336, 3024812789, 3021982861, 3006894636, 2183553, 2126677, 3004526608
FEI number
3021032044, 3019834893, 3022719374, 3015169361, 3007545404, 3002808157, 3016686005, 3017927156, 3022745617, 3013410552, 3004363352, 3031194398, 3015232217, 3036758982, 3007120336, 3024812789, 3021982861, 3006894636, 2183553, 3002619595, 2126677, 3004526608
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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.