510(k) K193210
K193210 is an FDA 510(k) premarket notification submitted by Shanghai United Imaging Healthcare Co., Ltd. for the device "HYPER DLR". The FDA issued a decision of Substantially Equivalent on Aug 4, 2020. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Shanghai United Imaging Healthcare Co., Ltd. has 84 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 2020
- Date Received
- Nov 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)