# Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263048 |
| Device | Syngo Carbon Space (VA4) |
| Applicant | Siemens Healthineers AG |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-31 |
| Decision date | 2026-09-29 |
| Review time (days) | 29 |
| Third-party review | Yes |
| Applicant location | Forchheim, DE |

## Why this score
- Fast 29-day review: this device is a strong predicate for similar products.
- Reviewed through the third-party program.
- Posted 36 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263048). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.