Cleared Traditional

PHILIPS URO DIAGNOST MRF (K911098) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911098 · Philips Medical Systems, Inc. · Radiology device
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Jul 1991
Decision
113d
Days
Class 2
Risk

K911098 is an FDA 510(k) clearance for the PHILIPS URO DIAGNOST MRF. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on July 3, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K911098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date July 03, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 107d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 10
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K911098.
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