510(k) K242994
- Device
- OncoStudio (OS-01)
- Applicant
- Oncosoft. Co., Ltd.
- 510(k) number
- K242994
- Product code
- QKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-24
- Date received
- 2024-09-26
- Regulation
- 892.2050
- Classification name
- Radiological Image Processing Software For Radiation Therapy
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Boram Kim
- Address
- 37, Myeongmul-Gil, Seodaemun-Gu Seoul KR 03776 03776
FDA Registration Numbers
- 3022745617
- 3021032044
- 3017927156
- 3016686005
- 3007120336
- 3004526608
- 3022719374
- 3031194398
- 8043933
- 3002808157
- 3013410552
- 3015232217
- 3019834893
- 3036758982
- 2126677
- 3015169361
- 3004363352
- 3025309924
- 3007545404
- 3024812789
- 3021982861
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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