Cleared Traditional

K911098 - PHILIPS URO DIAGNOST MRF

K911098 is an FDA 510(k) clearance for PHILIPS URO DIAGNOST MRF, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

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

FDA 510(k) Submission Details - K911098

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
Combination Product No
PCCP Authorized No
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.

IXR Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K911098.
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
K913147 · Shimadzu Medical Systems · Sep 1991
TREATMENT TABLE
K910838 · Tri W-G, Inc. · Aug 1991
TANGENT IV
K912586 · Fischer Imaging Corp. · Aug 1991
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · Tri W-G, Inc. · Apr 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · Tri W-G, Inc. · Jan 1991
ELITE 5000
K905501 · Fischer Imaging Corp. · Jan 1991