K241922
- 510(k) number
- K241922
- Device name
- Myomics
- Applicant
- Phantomics, Inc. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-02-28
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241922.pdf
Official FDA record: K241922
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.