510(k) K203535
K203535 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation Medical Systems for the device "Trinias". The FDA issued a decision of Substantially Equivalent on Apr 28, 2021. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2021
- Date Received
- Dec 3, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
- 510(k)
Interventional fluoroscopy