Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris
Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris (California): 510(k) cleared for Syneris. Its amount of 110 is below the median of 138 (40th percentile). Dated 42 days ago, it serves as a historical benchmark. 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: 110 · 40th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261874 |
| Device | Syneris PACS v.1.0.1.0 |
| Applicant | Syneris |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-05 |
| Decision date | 2026-09-23 |
| Review time (days) | 110 |
| Third-party review | No |
| Applicant location | Concord, CA |
| amount percentile | 40th of 414 (median 138, 0.8x median) |
| Peer records CSV (76 CA records) | 🔒 Click to unlock → |
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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: 2026-09-23
- Data refreshed: 2026-11-03
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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: Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris and 76 California peers
- California FDAPulse records like this one: 76
- Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris's amount: 40th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 110-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris in California?
Syneris PACS v.1.0.1.0 (K261874) by Syneris was cleared on 2026-09-23 after 110 days of review.
How does Syneris PACS v.1.0.1.0 (K261874): 510(k) cleared for Syneris compare to other California FDAPulse records?
Its amount of 110 is below the median (40th percentile); smaller records often move faster and face less competition. It is 42 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.
Syneris PACS v.1.0.1.0 (K261874) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Syneris PACS v.1.0.1.0 (K261874) | CA | 2026-09-23 |
| VenusCT (K260510) | CA | 2026-10-19 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
| BlineSlide (K261679) | CA | 2026-10-23 |
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