Cleared Traditional

K093596 - LUMOS, MODEL R 72B

K093596 is an FDA 510(k) clearance for LUMOS, manufactured by Lumos, Inc.. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K093596 · Lumos, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
53d
Days
Class 2
Risk

K093596 is an FDA 510(k) clearance for the LUMOS, MODEL R 72B. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by Lumos, Inc. (Naples, US). The FDA issued a Cleared decision on January 12, 2010 after a review of 53 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.

FDA 510(k) Submission Details - K093596

510(k) Number K093596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2009
Decision Date January 12, 2010
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
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 13
Devices cleared under the same product code (KPW) and FDA review panel - the closest regulatory comparables to K093596.
COLLIMATOR, MODEL M-38
K062788 · Umi International · Dec 2006
R 72
K030487 · Ralco S.R.L. · Aug 2003
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
K093596 · LUMOS, MODEL R 72B
Download PDF FDA Summary Lumos, Inc.