510(k) K201156
K201156 is an FDA 510(k) premarket notification submitted by Siemens Medical Solution USA, Inc. for the device "ARTIS pheno (VE2)". The FDA issued a decision of Substantially Equivalent on Jun 29, 2020. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Siemens Medical Solution USA, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 2020
- Date Received
- Apr 30, 2020
- 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