510(k) clearance
Syneris PACS v.1.0.1.0
- 510(k) number
- K261874
- Applicant
- Syneris
- Decision date
- Sep 23, 2026
- Date received
- Jun 5, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Concord, CA