510(k) K170909
K170909 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Coroporation for the device "Infinix INFX-8000V, V6.40". The FDA issued a decision of Substantially Equivalent on Jun 16, 2017. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Toshiba Medical Systems Coroporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2017
- Date Received
- Mar 28, 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