Cleared Special

K212837 - ProxiDiagnost N90 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212837 · Philips Medical Systems Dmc GmbH · Radiology device
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Sep 2021
Decision
14d
Days
Class 2
Risk

K212837 is an FDA 510(k) clearance for the ProxiDiagnost N90. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 21, 2021 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Medical Systems Dmc GmbH devices

Submission Details

510(k) Number K212837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2021
Decision Date September 21, 2021
Days to Decision 14 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 298
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