Cleared Traditional

K030487 - R 72

K030487 is an FDA 510(k) clearance for R 72, manufactured by Ralco S.R.L.. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K030487 · Ralco S.R.L. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
168d
Days
Class 2
Risk

K030487 is an FDA 510(k) clearance for the R 72. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by Ralco S.R.L. (Deerfield, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 168 days - an extended review 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: 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.

FDA 510(k) Submission Details - K030487

510(k) Number K030487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2003
Decision Date August 01, 2003
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPW Device Classification - Class 2, Special Controls

Product Code KPW Device, Beam Limiting, X-ray, Diagnostic
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 - KPW Device, Beam Limiting, X-ray, Diagnostic

All 11
Devices cleared under the same product code (KPW) and FDA review panel - the closest regulatory comparables to K030487.
LUMOS, MODEL R 72B
K093596 · Lumos, Inc. · Jan 2010
COLLIMATOR, MODEL M-38
K062788 · Umi International · Dec 2006
BLA-800A
K954310 · Toshiba Medical Systems · Oct 1995
R 302
K946320 · Ralco S.R.L. · May 1995
P2020-8-0 BEAM-LIMITING DEVICE
K914184 · Precise Optics · Nov 1991
DENSICOMP 250
K904587 · L. Keroack Co. · Jan 1991
K030487 · R 72
Download PDF FDA Summary Ralco S.R.L.