1.5T 24E Posterior Array
FDA 510(k) K223203 · Shenzhen RF Tech Co., Ltd.
510(k) numberK223203
Submission
- Device name
- 1.5T 24E Posterior Array
- Applicant
- Shenzhen RF Tech Co., Ltd.
Shenzhen, CN - Received
- October 14, 2022
- Decision date
- March 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 1.5T 24E Posterior Array cleared by the FDA?
1.5T 24E Posterior Array (K223203) received a 510(k) decision of Substantially Equivalent on March 2, 2023, 139 days after the submission was received.
What is the product code of K223203?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.