510(k) K123508
K123508 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation for the device "TRINIAS". The FDA issued a decision of Substantially Equivalent on February 26, 2014. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corporation has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2014
- Date Received
- November 13, 2012
- Clearance Type
- Abbreviated
- 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
Interventional fluoroscopy