510(k) K221922
K221922 is an FDA 510(k) premarket notification submitted by Shimadzu Corporation Medical Systems Division for the device "Trinias". The FDA issued a decision of Substantially Equivalent on Jul 28, 2022. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corporation Medical Systems Division has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2022
- Date Received
- Jul 1, 2022
- Clearance Type
- Special
- 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