510(k) K201583
K201583 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "SmartCT R1.0". The FDA issued a decision of Substantially Equivalent on Feb 9, 2021. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 9, 2021
- Date Received
- Jun 11, 2020
- Clearance Type
- Abbreviated
- 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