510(k) Report

510(k) · Cleared

Cleared

CT/Mri Topographic Marker

K930752510(k) TraditionalCleared Nov 19, 1993280-day reviewClass I21 CFR 892.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

I.Z.I. Corp. · JAC System, X-Ray, Film Marking, Radiographic

Cleared on Nov 19, 1993 after a 280-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 19, 1993
Review
280 days
Class
Class I
Product code
JAC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK930752 CT/Mri Topographic MarkerI.Z.I. Corp. · 1993
  2. Descendant · cites it directly · 0 of its ownK970608 Evt Marker BoardGuidant Cardiac and Vascular Surgery · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970608Evt Marker BoardGuidant Cardiac and Vascular Surgery · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930752CT/Mri Topographic MarkerI.Z.I. Corp.1993—
+1K970608Evt Marker BoardGuidant Cardiac and Vascular Surgery1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K930752, 1993–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970608Evt Marker BoardGuidant Cardiac and Vascular Surgery19970

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K970608 (Guidant Cardiac and Vascular Surgery, 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JAC devices

JAC System, X-Ray, Film Marking, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAC

FDA has decided no JAC device since 2007.

Median 510(k) review, days · JAC

Too few JAC 510(k)s in any year since 2007 to give a median.

Recalls per year · JAC

3in 2012

2012: 32026 (partial year): 1
2007high 3 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAC

1in 2025

2012: 52013: 12014: 12015: 12016: 12017: 12018: 42019: 42024: 22025: 1
2007high 5 (2012) · low 0 (2007)2025

MAUDE reports naming product code JAC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—35
20130—01
20140—01
20150—01
20160—01
20170—01
20180—04
20190—04
20200—00
20210—00
20220—00
20230—00
20240—02
20250—01
20260—1—

More from I.Z.I. Corp.

7 FDA decisions under this applicant name. See the company

  • K022074SpherzI.Z.I. Corp. · 200225 recalls
  • K014022Mri Line MarkerI.Z.I. Corp. · 20021 recall
  • K003736Mri Line MarkerI.Z.I. Corp. · 2001
  • K994117MR EnhancerI.Z.I. Corp. · 2000
  • K993742Super TissueI.Z.I. Corp. · 2000

Recent decisions in JAC

The JAC category page

  • K942883Digital I.D. CameraMiles Inc., Agfa Division · 1994
  • K932357Fuji EC ID CameraFujifilm Medical System U.S.A., Inc. · 1993
  • K925892Solstice Xray Ring Marker PadSolstice Corp. · 1993
  • K923533AdmarkPlanmeca USA, Inc. · 1993
  • K926404Kodak X-Omatic Identification Camera, Model 4 & 4LEastman Kodak Company · 1993

https://510kreport.com/device/K930752 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930752: CT/Mri Topographic Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930752

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026