Cleared Traditional

K963406 - UHE COLLIMATOR (210591)

K963406 is the FDA 510(k) clearance for UHE COLLIMATOR (210591) by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code KPS) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K963406 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Feb 1997
Decision
181d
Days
Class 2
Risk

K963406 is an FDA 510(k) clearance for the UHE COLLIMATOR (210591). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on February 26, 1997 after a review of 181 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 (Cleveland), Inc. devices

Submission Details

510(k) Number K963406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date February 26, 1997
Days to Decision 181 days
Submission Type Traditional
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
74d slower than avg
Panel avg: 107d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 242
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K963406.
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K970627 · Siemens Medical Solutions USA, Inc. · Sep 1997
VANTAGE 2.1 EXSPECT
K971878 · Adac Laboratories · Aug 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · Siemens Corp. · Mar 1997
PRISM XPVT SYSTEM (210823)
K964712 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · Elscint, Inc. · Jan 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · GE Medical Systems · Jan 1997