Syngo Carbon Space (VA4)— 510(k) K263048
Substantially EquivalentSiemens Healthineers AG
FDA 510(k) clearance K263048 for Syngo Carbon Space (VA4), Substantially Equivalent on 2026-09-29. Applicant: Siemens Healthineers AG. Device class: 2.
Summary
Syngo Carbon Space (VA4) from Siemens Healthineers AG is filed under LLZ, radiological image processing systems. "VA4" reads as a version designation. The record doesn't describe its features beyond the code.
Class II, 21 CFR 892.2050, Radiology panel, Traditional 510(k). The record flags it as a third-party review.
Siemens Healthineers AG filed from Forchheim, Germany. Review took 29 days (August 31 to September 29, 2026).
Clearance details
- Applicant
- Siemens Healthineers AG
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Forchheim, DE
Recent devices under product code LLZ
view allMore clearances from Siemens Healthineers AG
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.