Deep Learning Image Reconstruction
FDA 510(k) K213999 · Ge Medical Systems, LLC
510(k) numberK213999
Submission
- Device name
- Deep Learning Image Reconstruction
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- December 21, 2021
- Decision date
- February 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
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Questions and answers
When was Deep Learning Image Reconstruction cleared by the FDA?
Deep Learning Image Reconstruction (K213999) received a 510(k) decision of Substantially Equivalent on February 18, 2022, 59 days after the submission was received.
What is the product code of K213999?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.