FDA cleared Rapid ICH version 4.0, RapidAI's software for triage and notification of intracranial hemorrhage, under 510(k) K262301. The clearance includes an authorized predetermined change control plan, which lets RapidAI make certain planned model updates without a new submission.
Our readThe change control plan means future updates can reach sites faster. The FDA record does not describe what changed in version 4.0, so ask RapidAI for the performance data behind it.