510(k) K242515
K242515 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "uDR 380i Pro". The FDA issued a decision of Substantially Equivalent on October 10, 2024. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Shanghai United Imaging Healthcare Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2024
- Date Received
- August 23, 2024
- 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