510(k) K250597
K250597 is an FDA 510(k) premarket notification submitted by Remedi, Inc. for the device "REMEX Xcam6". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2025
- Date Received
- February 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type