Cleared Traditional

MAMMORX

K930246 · Diacor, Inc. · Radiology
Jul 1993
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K930246 is an FDA 510(k) clearance for the MAMMORX, 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 July 26, 1993, 188 days after receiving the submission on January 19, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K930246 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1993
Decision Date July 26, 1993
Days to Decision 188 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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