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9 510(K) Summary of Safe - accessdata fda

9 510(K) Summary of Safe - accessdata fda 2025

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The document is a 510(k) summary for the MRJExtended, a magnetic resonance diagnostic device manufactured by Paramed SRL. It outlines the manufacturer's information, intended use of the device for diagnostic imaging of various body parts including the L-Spine, and its substantial equivalence to predicate devices. The summary also includes regulatory details and compliance requirements as determined by the FDA.

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How long does a 510 K review take?

Subject to the FDAs acceptance review in ance with the guidance Refuse to Accept Policy for 510(k)s, the FDA generally reviews Abbreviated 510(k) submissions within 90 days of receipt.

What is 510k FDA approval?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the difference between 510K and FDA approval?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

What is the difference between 501k and PMA?

510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

What is the FDA 510K summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, new devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

What is a 501k submission to the FDA?

The FDAs 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

Is 510 k the same as FDA approval?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act) that is not subject to premarket approval.

What is 501k submission?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the devices intended

9 510(K) Summary of Safe - accessdata fda 2025

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