Cleared Traditional

CT/MRI TOPOGRAPHIC MARKER

K930752 · I.Z.I. Corp. · Radiology

Nov 1993

Decision

280d

Days

Class 1

Risk

About This 510(k) Submission

K930752 is an FDA 510(k) clearance for the CT/MRI TOPOGRAPHIC MARKER, a System, X-ray, Film Marking, Radiographic (Class I — General Controls, product code JAC), submitted by I.Z.I. Corp. (Owings Mills, US). The FDA issued a Cleared decision on November 19, 1993, 280 days after receiving the submission on February 12, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1640.

Submission Details

510(k) Number	K930752 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 1993
Decision Date	November 19, 1993
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement