Spine Auto Views
FDA 510(k) K223424 · GE Medical Systems SCS
510(k) numberK223424
Submission
- Device name
- Spine Auto Views
- Applicant
- GE Medical Systems SCS
Buc, FR - Received
- November 14, 2022
- Decision date
- July 13, 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 Spine Auto Views cleared by the FDA?
Spine Auto Views (K223424) received a 510(k) decision of Substantially Equivalent on July 13, 2023, 241 days after the submission was received.
What is the product code of K223424?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.