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- MiscellaneousMiscellaneous
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Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan
- Page Type
- Product Code
- Definition
- A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.
- Physical State
- Software device.
- Technical Method
- Software implementing artificial intelligence including adaptive machine learning algorithms trained with clinical and/or artificial data. The training data typically impacts generalizability of the device. The device involves a specific plan for how the machine learning algorithms could be modified in the future.
- Target Area
- The device operates on radiological images of the human body.
- Regulation Medical Specialty
- Radiology
- Review Panel
- Radiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 892.2055
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QVD is linked to regulation 21CFR892.2055, which does not seem to exist yet. It may be pending at the moment.