Cleared Traditional

K050092 - R605 FACS COLLIMETER

K050092 is an FDA 510(k) clearance for R605 FACS COLLIMETER, manufactured by Omega Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IZW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K050092 · Omega Medical Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
17d
Days
Class 2
Risk

K050092 is an FDA 510(k) clearance for the R605 FACS COLLIMETER. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by Omega Medical Imaging, Inc. (Sanford, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 17 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 Omega Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K050092

510(k) Number K050092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2005
Decision Date January 31, 2005
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
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 11
Devices cleared under the same product code (IZW) and FDA review panel - the closest regulatory comparables to K050092.
SHIMADZU COLLIMATOR R-300
K101039 · Shimadzu Corp. · Sep 2010
SHIMADZU COLLIMATOR R-30H
K090578 · Shimadzu Corp. · Nov 2009
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · Philips Medical Systems North America Co. · Jul 2003
PHILIPS NICOL COLLIMATOR FAMILY
K990423 · Philips Medical Systems, Inc. · Mar 1999
XRE COLLIMATOR
K960998 · Xre Corp. · Apr 1996
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
K951372 · Philips Medical Systems, Inc. · May 1995