510(k) K253264
K253264 is an FDA 510(k) premarket notification submitted by Siemens Healthcare GmbH for the device "myAblation Guide (VC10A)". The FDA issued a decision of Substantially Equivalent on June 16, 2026. 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. Siemens Healthcare GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2026
- Date Received
- September 29, 2025
- 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.