Cleared Traditional

LUMOS, MODEL R 72B

K093596 · Lumos, Inc. · Radiology
Jan 2010
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K093596 is an FDA 510(k) clearance for the LUMOS, MODEL R 72B, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by Lumos, Inc. (Naples, US). The FDA issued a Cleared decision on January 12, 2010, 53 days after receiving the submission on November 20, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K093596 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KPW — Device, Beam Limiting, X-ray, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610