510(k) K203551
K203551 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Alphenix, INFX-8000V/B, /S, V9.1". The FDA issued a decision of Substantially Equivalent on Dec 18, 2020. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 18, 2020
- Date Received
- Dec 4, 2020
- 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