Deep Learning Image Reconstruction
FDA 510(k) K220961 · Ge Healthcare Japan Corporation
510(k) numberK220961
Submission
- Device name
- Deep Learning Image Reconstruction
- Applicant
- Ge Healthcare Japan Corporation
Hino, JP - Received
- April 1, 2022
- Decision date
- July 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Siemens Medical Solutions USA, Inc.
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|---|---|---|
| K253686 | True Definition DLJAK · Traditional | 03/23/2026SE |
| K233698 | True Enhance DLJAK · Traditional | 04/11/2024SE |
| K230807 | Deep Learning Image ReconstructionJAK · Special | 04/20/2023SE |
| K213938 | Revolution AscendJAK · Traditional | 02/04/2022SE |
| K212067 | Deep Learning Image ReconstructionJAK · Traditional | 09/17/2021SE |
| K203169 | Revolution AscendJAK · Special | 11/20/2020SE |
| K193170 | Deep Learning Image ReconstructionJAK · Special | 12/13/2019SE |
| K143345 | SIGNA PioneerLNH · Traditional | 07/10/2015SE |
| K103327 | Discovery MR750W 3.0TLNH · Traditional | 09/30/2011SE |
Questions and answers
When was Deep Learning Image Reconstruction cleared by the FDA?
Deep Learning Image Reconstruction (K220961) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 119 days after the submission was received.
What is the product code of K220961?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.