Cleared Traditional

RADASSIST

K934566 · Diacor, Inc. · Radiology
Nov 1993
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K934566 is an FDA 510(k) clearance for the RADASSIST, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 3, 1993, 43 days after receiving the submission on September 21, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K934566 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1993
Decision Date November 03, 1993
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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