Cleared Traditional

WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE

K981470 · Worldwide Medical Technologies, LLC · Radiology
Jun 1998
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K981470 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on June 19, 1998, 57 days after receiving the submission on April 23, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K981470 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1998
Decision Date June 19, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710