Syneris PACS v.1.0.1.0— 510(k) K261874
Substantially EquivalentSyneris
FDA 510(k) clearance K261874 for Syneris PACS v.1.0.1.0, Substantially Equivalent on 2026-09-23. Applicant: Syneris. Device class: 2.
Summary
Syneris PACS (version 1.0.1.0) is a picture archiving and communication system filed under LLZ, radiological image processing systems. The record doesn't describe its features beyond the name and code.
Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).
Syneris filed from Concord, California. Review took 110 days (June 5 to September 23, 2026).
Clearance details
- Applicant
- Syneris
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA
Recent devices under product code LLZ
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.