Auto Segmentation
FDA 510(k) K230082 · Ge Medical Systems, LLC
510(k) numberK230082
Submission
- Device name
- Auto Segmentation
- Applicant
- Ge Medical Systems, LLC
Waukesha, WI, US - Received
- January 11, 2023
- Decision date
- May 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
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Questions and answers
When was Auto Segmentation cleared by the FDA?
Auto Segmentation (K230082) received a 510(k) decision of Substantially Equivalent on May 4, 2023, 113 days after the submission was received.
What is the product code of K230082?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.