K252988
- 510(k) number
- K252988
- Device name
- ChartCheck (RADCH V1.6)
- Applicant
- Radformation, Inc. NY · US
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2026-01-05
- Date received
- 2025-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252988.pdf
Official FDA record: K252988
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.