Cleared Traditional

K083029 - MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083029 · Ralco S.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
56d
Days
Class 2
Risk

K083029 is an FDA 510(k) clearance for the MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR. Classified as Collimator, Automatic, Radiographic (product code IZW), Class II - Special Controls.

Submitted by Ralco S.R.L. (Deer Field, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 56 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 Ralco S.R.L. devices

Submission Details

510(k) Number K083029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2008
Decision Date December 05, 2008
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.