Cleared Special

K181797 - Philips CT Big Bore Sliding Gantry Conf...

K181797 is an FDA 510(k) clearance for Philips CT Big Bore Sliding Gantry Conf..., manufactured by Phillips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 29-day FDA review.

K181797 · Phillips Medical Systems (Cleveland), Inc. · Radiology device
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Aug 2018
Decision
29d
Days
Class 2
Risk

K181797 is an FDA 510(k) clearance for the Philips CT Big Bore Sliding Gantry Configuration. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Phillips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on August 3, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Phillips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K181797

510(k) Number K181797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2018
Decision Date August 03, 2018
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 635
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