Cleared Traditional

K990423 - PHILIPS NICOL COLLIMATOR FAMILY

K990423 is an FDA 510(k) clearance for PHILIPS NICOL COLLIMATOR FAMILY, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IZW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K990423 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
32d
Days
Class 2
Risk

K990423 is an FDA 510(k) clearance for the PHILIPS NICOL COLLIMATOR FAMILY. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Medical Systems, Inc. devices

FDA 510(k) Submission Details - K990423

510(k) Number K990423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date March 15, 1999
Days to Decision 32 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
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZW Device Classification - Class 2, Special Controls

Product Code IZW Collimator, Automatic, Radiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 - IZW Collimator, Automatic, Radiographic

All 14
Devices cleared under the same product code (IZW) and FDA review panel - the closest regulatory comparables to K990423.
COLLIMARE COLLIMATOR FAMILY
K073124 · Collimare, LLC · Nov 2007
R605 FACS COLLIMETER
K050092 · Omega Medical Imaging, Inc. · Jan 2005
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · Philips Medical Systems North America Co. · Jul 2003
XRE COLLIMATOR WITH SPECTRAL FILTER
K984414 · Trex Medical Corp. · Dec 1998
XRE COLLIMATOR
K960998 · Xre Corp. · Apr 1996
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
K951372 · Philips Medical Systems, Inc. · May 1995