Trinias
K-Number: K221922 · 2022-07-28
Decision Date2022-07-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Trinias is a medical device manufactured by Shimadzu Corporation Medical Systems Division. It received FDA 510(k) clearance on 2022-07-28 under approval number K221922. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Trinias?
Trinias is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Shimadzu Corporation Medical Systems Division. The 510(k) number is K221922.
When was Trinias approved by the FDA?
Trinias received FDA 510(k) clearance on 2022-07-28, under approval number K221922.
What company makes Trinias?
Trinias is manufactured by Shimadzu Corporation Medical Systems Division.
What is the FDA product code for Trinias?
The FDA product code for Trinias is OWB.
Other Devices by Shimadzu Corporation Medical Systems Division
Related Devices (Code: OWB)
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.
K162148Allura Xper R9Philips Medical Systems Nethrlands BV
K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation
K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.
K161976Ziehm Solo FDZiehm Imaging GmbH
K161756SyncVision SystemVolcano Corporation
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.