510(k) K263048
K263048 is an FDA 510(k) premarket notification submitted by Siemens Healthineers AG for the device "Syngo Carbon Space (VA4)". The FDA issued a decision of Substantially Equivalent on Sep 29, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Healthineers AG has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2026
- Date Received
- Aug 31, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)