510(k) K261943
K261943 is an FDA 510(k) premarket notification submitted by Remedi, Inc. for the device "REMEX-T(K)100C". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Remedi, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2026
- Date Received
- Jun 10, 2026
- 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
- 510(k)