510(k) K234108
K234108 is an FDA 510(k) premarket notification submitted by Energy Resources International Co., Ltd. for the device "ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)". The FDA issued a decision of Substantially Equivalent on September 20, 2024. 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
- September 20, 2024
- Date Received
- December 27, 2023
- 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