RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE
RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE (Delaware): 510(k) cleared for Brainlab SE. Its amount of 139 is above the median of 138 (51st percentile). Dated 30 days ago, it is in the active follow-up window. Score 36/100. 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: 139 · 51th percentile of 414 FDAPulse records · 1.0x 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 | K261655 |
| Device | RT Elements (4.6) |
| Applicant | Brainlab SE |
| Specialty / panel | Radiology |
| Product code | MUJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-19 |
| Decision date | 2026-10-05 |
| Review time (days) | 139 |
| Third-party review | No |
| Applicant location | Munich, DE |
| amount percentile | 51th of 414 (median 138, 1.0x 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: 2026-10-05
- 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: RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE's amount: 51st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 139-day review: this device is a strong predicate for similar products.
- Posted 30 days ago.
What is the FDAPulse record for RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE in Delaware?
RT Elements (4.6) (K261655) by Brainlab SE was cleared on 2026-10-05 after 139 days of review.
How does RT Elements (4.6) (K261655): 510(k) cleared for Brainlab SE compare to other Delaware FDAPulse records?
Its amount of 139 sits in the upper half (51th percentile) of 414 records; the median is 138. It is 30 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
RT Elements (4.6) (K261655) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| RT Elements (4.6) (K261655) | DE | 2026-10-05 |
| 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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