Cleared Special

K163410 - DigitalDiagnost C50

K163410 is the FDA 510(k) clearance for DigitalDiagnost C50 by Philips Healthcare (Suzhou) Co., Ltd.. It is a Class 2 Radiology device (product code KPR) cleared through the Special 510(k) pathway after a 30-day FDA review.

K163410 · Philips Healthcare (Suzhou) Co., Ltd. · Radiology device
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Jan 2017
Decision
30d
Days
Class 2
Risk

K163410 is an FDA 510(k) clearance for the DigitalDiagnost C50. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 4, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Healthcare (Suzhou) Co., Ltd. devices

Submission Details

510(k) Number K163410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date January 04, 2017
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

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