Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Trinias

K-Number: K203535 · 2021-04-28

ApplicantShimadzu Corporation Medical Systems
Decision Date2021-04-28
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Trinias is a medical device manufactured by Shimadzu Corporation Medical Systems. It received FDA 510(k) clearance on 2021-04-28 under approval number K203535. 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 2021-04-28. It is manufactured by Shimadzu Corporation Medical Systems. The 510(k) number is K203535.

When was Trinias approved by the FDA?

Trinias received FDA 510(k) clearance on 2021-04-28, under approval number K203535.

What company makes Trinias?

Trinias is manufactured by Shimadzu Corporation Medical Systems.

What is the FDA product code for Trinias?

The FDA product code for Trinias is OWB.

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.

↑