510(k) K182546
K182546 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Alphenix, INFX-8000H/B, V8.0". The FDA issued a decision of Substantially Equivalent on Oct 17, 2018. 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
- Oct 17, 2018
- Date Received
- Sep 17, 2018
- 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