Cleared Traditional

K014022 - MRI LINE MARKER
(FDA 510(k) Clearance)

K014022 · I.Z.I. Corp. · Radiology

Mar 2002

Decision

88d

Days

Class 2

Risk

K014022 is an FDA 510(k) clearance for the MRI LINE MARKER. This device is classified as a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE).

Submitted by I.Z.I. Corp. (Baltimore, US). The FDA issued a Cleared decision on March 4, 2002, 88 days after receiving the submission on December 6, 2001.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K014022 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2001
Decision Date	March 04, 2002
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement