510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930752Substantially Equivalent

Ct/mri Topographic Marker

I.Z.I. Corp., Owings Mills MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930752 is the FDA 510(k) clearance record for CT/MRI TOPOGRAPHIC MARKER, a class I device, cleared for I.Z.I. Corp. on under FDA product code JAC (System, X-Ray, Film Marking, Radiographic). FDA records list 3 510(k) clearances for I.Z.I. Corp., from to . As of , FDA records show no recalls naming K930752.

Clearance record

Decision date
Received
(280 days to decision)
Product code
JAC System, X-Ray, Film Marking, Radiographic
Regulation
21 CFR 892.1640
Device class
Class I
Review panel
Radiology
Applicant
I.Z.I. Corp. 10 Stream Ct., Owings Mills MD
510(k) summary
Statement
Third party review
No

Clearances, product code JAC

Trailing 12 months

FDA records hold no clearances under product code JAC in the trailing twelve months.

FDA records show no clearances under product code JAC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260