ChartCheck (RADCH V1.6)
K-Number: K252988 · 2026-01-05
ApplicantRadformation, Inc.
Decision Date2026-01-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ChartCheck (RADCH V1.6) is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2026-01-05 under approval number K252988. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ChartCheck (RADCH V1.6)?
ChartCheck (RADCH V1.6) is a medical device that received FDA 510(k) clearance on 2026-01-05. It is manufactured by Radformation, Inc.. The 510(k) number is K252988.
When was ChartCheck (RADCH V1.6) approved by the FDA?
ChartCheck (RADCH V1.6) received FDA 510(k) clearance on 2026-01-05, under approval number K252988.
What company makes ChartCheck (RADCH V1.6)?
ChartCheck (RADCH V1.6) is manufactured by Radformation, Inc..
What is the FDA product code for ChartCheck (RADCH V1.6)?
The FDA product code for ChartCheck (RADCH V1.6) is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.