I had the following conversation with ChatGPT.
Could you guys comment on that?
Is 3D Slicer really FDA-cleared?
Yes, 3D Slicer is FDA-cleared for certain clinical applications. In August 2019, 3D Slicer was granted FDA clearance as a Class II medical device for use in radiological image viewing, analysis, and annotation for the following indications:
Visualization and quantification of anatomical structures and regions of interest.
Display and analysis of functional imaging data (such as MRI, CT, PET, and SPECT).
Segmentation and labeling of anatomical structures.
The FDA clearance was granted to the 3D Slicer software version 4.10.2, and it applies to the software when used with compatible hardware and operating systems.
It’s worth noting that while 3D Slicer has been FDA-cleared for certain applications, it is important to carefully evaluate and validate any software tools used in medical image analysis to ensure they meet the specific needs of your application and comply with all regulatory requirements.
Yes, of course! If I made a mistake or provided incorrect information, please let me know so that I can correct myself.
3D Slicer is not FDA-cleared yet.
Thank you for letting me know! You are correct that 3D Slicer is not FDA-cleared for clinical use. While 3D Slicer is a powerful open-source medical imaging software platform that has been widely used in research and academic settings, it is important to note that its use in a clinical context should be evaluated and approved by relevant regulatory bodies and healthcare providers.
Trade Name: AIBOLIT 3D+ Image Processing System Type of Device/ Product Code: Radiological Image Processing System / QIH - LLZ Regulation / Class: 21 CFR 892.2050 – Class II
… 3D Image generation: 3D image file generated by 3rd party software (3D Slicer) following Radiologist review and approval of annotation
From informal discussions we know that there are a number of FDA-cleared products that use 3D Slicer (and there are several applications currently in progress) but so far I could not find any publicly shareable information, because typically low-level details such as the name of the internally used software platform (3D Slicer) do not appear in the public 510(k) Summary.
Yes, that’s the way it should be. Companies that want to take responsibility for selling medical products can use 3D Slicer technology under the terms of the license with no charge. 3D Slicer itself, as made available on slicer.org is not such a product. Reading the pdf that Andras linked to is a good way to get a sense of the legal process of selling a medical product.
Nice find indeed - @lassoan and @pieper could you maybe correct ChatGPT if my last entered information is not correct? I think it would be great to have that detail taken care of although I know that you are somewhat reserved concerning this tool. Thank you.
I’m not sure it really learns from corrections. I tired your original query to chatGPT and it gave the same wrong answer you got originally. I told it it was wrong and it gave the right answer, but I suppose next time someone asks it will give the wrong answer again.
This is false. “3D Slicer” is not a product cleared or approved by FDA.
The fact that 3D Slicer is used in FDA-cleared products, does not make 3D Slicer itself an FDA-cleared product. Similarly, although Windows operating system is used in thousands of FDA-cleared products, it does not make Windows itself an FDA-cleared product.
The 510(k) summary linked above just demonstrates that you can build FDA-cleared products that use 3D Slicer.
I find that ChatGPT is very eager to please. It very rarely says no or rejects to answer a question. However, the answers are often incorrect, so you always need to check it. Often if you ask more specific details then it admits that it was incorrect. For example:
Is 3D Slicer really FDA-cleared?
ChatGPT answer (confident but wrong):
Yes, 3D Slicer is FDA-cleared. The software was cleared by the FDA in 2011 for use in clinical environments. The clearance was specifically for the use of 3D Slicer in radiological imaging for the purposes of diagnosis, treatment planning, and image-guided intervention.
3D Slicer is a free, open-source software platform for medical image analysis and visualization. It is widely used by researchers, clinicians, and developers around the world for a variety of medical applications. The software has been developed by a large community of contributors over many years, and it continues to be actively developed and maintained.
Can you provide a link to the FDA clearance?
ChatGPT answer (still confident, still wrong):
Yes, here is a link to the FDA clearance letter for 3D Slicer:
This letter confirms that 3D Slicer was cleared by the FDA for use in clinical environments for the purposes of diagnosis, treatment planning, and image-guided intervention based on its compliance with the relevant regulatory requirements.
This letter is not about 3D Slicer. Can you provide another link?
ChatGPT answer (correct):
I apologize for the confusion. After further investigation, it appears that 3D Slicer is not actually FDA-cleared as a medical device. While 3D Slicer has been used in numerous clinical applications, including for research purposes and medical education, it does not have FDA clearance or approval as a medical device for any specific clinical use.
My earlier response was incorrect, and I apologize for any confusion or misinformation that may have caused. Thank you for bringing this to my attention.
Interestingly, if you ask ChatGPT slightly differently (FDA approval instead of clearance), it gives correct and comprehensive answer with good insight:
Is 3D Slicer FDA-approved for image-guided therapy?
3D Slicer is a free and open-source software platform for medical image analysis, visualization, and image-guided therapy research. However, it is important to note that 3D Slicer is not an FDA-approved medical device.
While 3D Slicer has been used in various clinical applications and research studies, including image-guided therapy, it is ultimately up to the clinician or researcher to ensure that the use of 3D Slicer meets all necessary regulatory requirements and standards for their specific application.
It is also worth noting that the FDA does not typically “approve” specific software programs like 3D Slicer. Instead, the FDA regulates the use of medical devices and software through a premarket clearance or approval process, which evaluates the safety and effectiveness of the device or software for its intended use. However, 3D Slicer may still be used in research studies or other applications where FDA clearance or approval is not required.