Cleared Traditional

FACTS MONOBLOCK

K981267 · Dynarad Corp. · Radiology
May 1998
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K981267 is an FDA 510(k) clearance for the FACTS MONOBLOCK, a Collimator, Manual, Radiographic (Class II — Special Controls, product code IZX), submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on May 6, 1998, 29 days after receiving the submission on April 7, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K981267 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1998
Decision Date May 06, 1998
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZX — Collimator, Manual, Radiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610