Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG
Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG (Delaware): 510(k) cleared for Siemens Healthineers AG. Its amount of 29 is below the median of 138 (7th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 41/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 29 · 7th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 7th of 414 (median 138, 0.2x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-29
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG's amount: 7th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 29-day review: this device is a strong predicate for similar products.
- Reviewed through the third-party program.
- Posted 36 days ago.
What is the FDAPulse record for Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG in Delaware?
Syngo Carbon Space (VA4) (K263048) by Siemens Healthineers AG was cleared on 2026-09-29 after 29 days of review.
How does Syngo Carbon Space (VA4) (K263048): 510(k) cleared for Siemens Healthineers AG compare to other Delaware FDAPulse records?
Its amount of 29 is below the median (7th percentile); smaller records often move faster and face less competition. It is 36 days old, still within a typical 45-day follow-up window.
Syngo Carbon Space (VA4) (K263048) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Syngo Carbon Space (VA4) (K263048) | DE | 2026-09-29 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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