K222222
- 510(k) number
- K222222
- Device name
- Artemis, Artemis TPO, Artemis MX
- Applicant
- Eigen CA · US
- Product code
- QTZ — Radiological Image Processing Software For Ablation
- Decision date
- 2023-10-12
- Date received
- 2022-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K222222.pdf
Official FDA record: K222222
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.