uCT ATLAS with uWS-CT-Dual Energy Analysis
Summary
Shanghai United Imaging Healthcare Co., Ltd. received 510(k) clearance for uCT ATLAS with uWS-CT-Dual Energy Analysis, a JAK device. Cleared on 2021-08-11.
Details
Source
510(k) Clearance
External ID
K203448
Action Date
2021-08-11
Status
Traditional
Category
device
Product Code
JAK
Product Description
uCT ATLAS with uWS-CT-Dual Energy Analysis. Product code: JAK.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Shanghai United Imaging Healthcare Co., Ltd. has received 43 total clearances in our database.
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Shanghai United Imaging Healthcare Co., Ltd. have FDA actions?
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K203448" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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