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Phoenix Ortho

Is your PACS software FDA510K approved?”


The question is more precisely: is your PACS “FDA Cleared”? The FDA approval process is reserved for Medical Devices which interact with patients and may adversely impact patient health. An example in this case would be the x-ray machine that passes x-rays through the patient’s body. This x-ray machine interacts with the patient to pose a potential health risk and would be a Medical Device requiring FDA Approval.


Phoenix Ortho XMR in the above equation is a “FDA Cleared” Class I exempt device under regulation 21 CFR 892.2020 (see notification attached). It is improper for any PACS vendor to say that they are FDA Approved. The Process is “FDA Clearance”. In the FDA clearance process Phoenix Ortho makes the case that their product is the “substantial equivalent” to a previously cleared device. Every FDA Cleared PACS vendor is required to be the “Substantial Equivalent” of another product previously cleared. Our Class I status allows us to Communicate (WLS) with the Modality, Store the DICOM Image in our PACS archive and Display the image in our Phoenix Ortho Viewer. The cleared Device may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol.

ALSO it is important to note that Phoenix Ortho XMR is the Only EHR to implement the 21 CFR 892.2010 utilizing the DICOM (WLS) standard for communications. This is extremely important for a large clinic with multiple locations and 10, 20, 30 or more modalities.

ADDITIONALLY: The FDA recently in June of 2015 issued new regulations intended to downgrade regulatory compliance due to the low risk they pose and the importance the play in advancing digital health. The Following is an excerpt from the Document attached “2015 MDDS Regs Class I”.

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Guidance for Industry and Food and Drug Administration Staff

The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.


On February 15, 2011, the FDA issued a regulation down-classifying MDDS from Class III (high-risk) to Class I (low-risk) (“MDDS regulation”).1 Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public. Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices.