510(k) · Cleared

Cleared

Evt Marker Board

K970608510(k) TraditionalCleared Apr 21, 199762-day reviewClass II21 CFR 892.1650

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

Guidant Cardiac and Vascular Surgery · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on Apr 21, 1997 as substantially equivalent to K930752 (I.Z.I. Corp., 1993) after a 62-day review. Its family tree reaches back 1 generation to 1993.

Decided: Apr 21, 1997
Review: 62 days
Class: Class II
Product code: JAA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K930752 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK930752 CT/Mri Topographic MarkerI.Z.I. Corp. · 1993
This deviceK970608 Evt Marker BoardGuidant Cardiac and Vascular Surgery · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930752	CT/Mri Topographic Marker	I.Z.I. Corp.	1993	—
0 (this device)	K970608	Evt Marker Board	Guidant Cardiac and Vascular Surgery	1997	—

FIG. 1 — Lineage of K970608, 1993–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new JAA device

#1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K930752	CT/Mri Topographic Marker Summary page 1 …py x-ray system, 21 CFR 892.1650, Class II. SUBSTANTIAL EQUIVALENCE: The EVT® Marker Board is substantially equivalent to the IZI Medical Products Topographic Marker, (K930752, Class II). The EVTX Marker Board is used external to the body. A control box is used to remotely move the position of the marker…	I.Z.I. Corp.	1993	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

How does its category compare?

All JAA devices

JAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAA

2in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAA

89in 2024

2007high 276 (2014) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAA

4in 2025

2007high 35 (2007) · low 1 (2014)2026

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

Adverse event reports per year · JAA

33in 2025

2007high 14,000 (2011) · low 25 (2024)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	35	9,517
2008	6	18	21	9,484
2009	0	—	18	12,040
2010	1	—	6	5,803
2011	4	48	7	14,000
2012	1	—	2	11,684
2013	6	129	3	13,706
2014	6	276	1	10,265
2015	3	197	1	2,922
2016	2	—	7	35
2017	1	—	3	56
2018	3	30	1	36
2019	6	49	2	49
2020	4	39	2	39
2021	6	104	2	35
2022	1	—	5	34
2023	2	—	9	41
2024	3	89	2	25
2025	2	—	4	33
2026	1	—	0	—

What is it indicated for?

The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970608 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970608: Evt Marker Board.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970608

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026