510(k) K171194
K171194 is an FDA 510(k) premarket notification submitted by Canon, Inc. for the device "AS-10, CXDI-401RF". The FDA issued a decision of Substantially Equivalent on May 24, 2017. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Canon, Inc. has 42 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2017
- Date Received
- Apr 24, 2017
- 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