Trinias— 510(k) K252099
Substantially EquivalentShimadzu Corporation
FDA 510(k) clearance K252099 for Trinias, Substantially Equivalent on 2026-03-24. Applicant: Shimadzu Corporation. Device class: 2.
Summary
Shimadzu's Trinias is filed under OWB, interventional fluoroscopic x-ray systems. The record gives only that one-word name, with no model numbers.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. It was an Abbreviated 510(k).
Shimadzu filed from Kyoto, Japan. The decision came 264 calendar days after receipt (July 3, 2025 to March 24, 2026).
Clearance details
- Applicant
- Shimadzu Corporation
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kyoto, JP
Recent devices under product code OWB
view allMore clearances from Shimadzu Corporation
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.