K243449
- 510(k) number
- K243449
- Device name
- INFINITT DPS
- Applicant
- Infinitt Healthcare Co., Ltd. KR
- Product code
- QKQ — Digital Pathology Image Viewing And Management Softw
- Decision date
- 2025-12-09
- Date received
- 2024-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243449.pdf
Official FDA record: K243449
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.