Cleared Traditional

HF-110A

K932353 · Dynarad Corp. · Radiology
Jan 1994
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K932353 is an FDA 510(k) clearance for the HF-110A, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on January 31, 1994, 263 days after receiving the submission on May 13, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K932353 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1993
Decision Date January 31, 1994
Days to Decision 263 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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