Cleared Special

K153318 - Philips Eleva Workspot with SkyFlow

K153318 is an FDA 510(k) clearance for Philips Eleva Workspot with SkyFlow, manufactured by Philips Medical Systems Dmc GmbH. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 34-day FDA review.

K153318 · Philips Medical Systems Dmc GmbH · Radiology device
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Dec 2015
Decision
34d
Days
Class 2
Risk

K153318 is an FDA 510(k) clearance for the Philips Eleva Workspot with SkyFlow. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on December 22, 2015 after a review of 34 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 Medical Systems Dmc GmbH devices

FDA 510(k) Submission Details - K153318

510(k) Number K153318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2015
Decision Date December 22, 2015
Days to Decision 34 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 288
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