510(k) K234067
K234067 is an FDA 510(k) premarket notification submitted by Medphoton GmbH for the device "ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)". The FDA issued a decision of Substantially Equivalent on March 28, 2025. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Medphoton GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2025
- Date Received
- December 22, 2023
- 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
Interventional fluoroscopy