Cleared Traditional

ELITE R/F SPOT FILM DRIVE

K902403 · Rms Div. · Radiology
Aug 1990
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K902403 is an FDA 510(k) clearance for the ELITE R/F SPOT FILM DRIVE, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by Rms Div. (Addison, US). The FDA issued a Cleared decision on August 1, 1990, 62 days after receiving the submission on May 31, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number K902403 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1990
Decision Date August 01, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IXL — Device, Spot-film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1670

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