510(k) K203448
K203448 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "uCT ATLAS with uWS-CT-Dual Energy Analysis". The FDA issued a decision of Substantially Equivalent on Aug 11, 2021. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Shanghai United Imaging Healthcare Co., Ltd. has 84 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2021
- Date Received
- Nov 23, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type
- 510(k)