Cleared Abbreviated

K073124 - COLLIMARE COLLIMATOR FAMILY

K073124 is an FDA 510(k) clearance for COLLIMARE COLLIMATOR FAMILY, manufactured by Collimare, LLC. The device is a Class 2 Radiology device with product code IZW cleared through the Abbreviated 510(k) pathway after a 10-day FDA review.

K073124 · Collimare, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
10d
Days
Class 2
Risk

K073124 is an FDA 510(k) clearance for the COLLIMARE COLLIMATOR FAMILY. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by Collimare, LLC (Arvada, US). The FDA issued a Cleared decision on November 16, 2007 after a review of 10 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K073124

510(k) Number K073124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2007
Decision Date November 16, 2007
Days to Decision 10 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 107d · This submission: 10d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZW Collimator, Automatic, Radiographic

All 22
Devices cleared under the same product code (IZW) and FDA review panel - the closest regulatory comparables to K073124.
RALCO, MODEL R225 ACS
K091517 · Ralco S.R.L. · Jul 2009
MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
K083029 · Ralco S.R.L. · Dec 2008
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
K072780 · Ralco S.R.L. · 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
PHILIPS NICOL COLLIMATOR FAMILY
K990423 · Philips Medical Systems, Inc. · Mar 1999
K073124 · COLLIMARE COLLIMATOR FAMILY
Download PDF FDA Summary Collimare, LLC