K250696
- 510(k) number
- K250696
- Device name
- AccuCheck
- Applicant
- Manteia Technologies Co., Ltd. CN
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2025-10-24
- Date received
- 2025-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250696.pdf
Official FDA record: K250696
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.