Optima CT520
FDA 510(k) K123596 · Ge Hangwei Medical Systems Co., Ltd.
510(k) numberK123596
Submission
- Device name
- Optima CT520
- Applicant
- Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN - Received
- November 21, 2012
- Decision date
- February 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Optima CT520 cleared by the FDA?
Optima CT520 (K123596) received a 510(k) decision of Substantially Equivalent on February 8, 2013, 79 days after the submission was received.
What is the product code of K123596?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.