K261713
- 510(k) number
- K261713
- Device name
- Synapse PACS (7.6.0)
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-18
- Date received
- 2026-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K261713.pdf
Official FDA record: K261713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.