Hitachi Healthcare Americas Corporation
Hitachi Healthcare Americas Corporation holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2018, with 4 FDA device recalls on record.
Top product codes for Hitachi Healthcare Americas Corporation
FDA recalls by Hitachi Healthcare Americas Corporation
- Z-2339-2021 — OASIS MRI System
- Z-2338-2021 — ECHELON Oval MRI System
- Z-2337-2021 — ECHELON MRI System
- Z-2308-2021 — Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hitachi Healthcare Americas Corporation
Data sourced from openFDA. This site is unofficial and independent of the FDA.