Cleared Traditional

LIGHTLINE-M

K974240 · Wuestec Medical, Inc. · Radiology
Dec 1997
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K974240 is an FDA 510(k) clearance for the LIGHTLINE-M, a Collimator, Manual, Radiographic (Class II — Special Controls, product code IZX), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on December 22, 1997, 40 days after receiving the submission on November 12, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K974240 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1997
Decision Date December 22, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZX — Collimator, Manual, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610