Emission Computed Tomography System
FDA 510(k) clearance K193241 · decided 2020-01-26
Clearance details
- K-number
- K193241
- Device name
- Emission Computed Tomography System
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-11-25
- Decision date
- 2020-01-26
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shanghai United Imaging Healthcare Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tom recall (Z-0223-2026) | UIH Technologies LLC | 2025-10-21 |
| Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Comput recall (Z-1353-2023) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-04-07 |
| Positron Emission Tomography and Computed Tomography System, Model: uMI 550 recall (Z-0087-2023) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-13 |