Cleared Traditional

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR

K953563 · Jamieson Film Co. · Radiology
Oct 1995
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K953563 is an FDA 510(k) clearance for the VANGUARD XR-350 CINEANGIOGRAM PROJECTOR, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Jamieson Film Co. (Dallas, US). The FDA issued a Cleared decision on October 5, 1995, 66 days after receiving the submission on July 31, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K953563 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1995
Decision Date October 05, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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