510(k) K222222
K222222 is an FDA 510(k) premarket notification submitted by Eigen for the device "Artemis, Artemis TPO, Artemis MX". The FDA issued a decision of Substantially Equivalent on October 12, 2023. The device falls under product code QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation), a Class II device regulated under 21 CFR 892.2050. Eigen has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2023
- Date Received
- July 25, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.