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K252988

ChartCheck (RADCH V1.6)

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.