OncoStudio— 510(k) K260528
Substantially EquivalentOncosoft. Inc.,
FDA 510(k) clearance K260528 for OncoStudio, Substantially Equivalent on 2026-07-02. Applicant: Oncosoft. Inc.,. Device class: 2.
Clearance details
- Applicant
- Oncosoft. Inc.,
- Product code
- Code QKB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code QKB
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