Cleared Traditional

L-LINEX-RAY FLUORESCENCE

K911749 · Montifore Medical Center · Radiology
Aug 1991
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K911749 is an FDA 510(k) clearance for the L-LINEX-RAY FLUORESCENCE, a Scanner, Fluorescent (Class II — Special Controls, product code JAO), submitted by Montifore Medical Center (Bronx, US). The FDA issued a Cleared decision on August 20, 1991, 124 days after receiving the submission on April 18, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1220.

Submission Details

510(k) Number K911749 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1991
Decision Date August 20, 1991
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAO — Scanner, Fluorescent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1220