K243647
- 510(k) number
- K243647
- Device name
- Synapse PACS (7.5)
- Applicant
- FUJIFILM Healthcare Americas Corporation MA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-06-30
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243647.pdf
Official FDA record: K243647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.