510(k) · Cleared

Recalled · Class I · 2009

Instatrak 3000

K983529510(k) TraditionalCleared Dec 31, 199884-day reviewClass II21 CFR 892.2050Recalls 6 (1 Class I)

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

Visualization Technology, Inc. · LLZ System, Image Processing, Radiological

Cleared on Dec 31, 1998 as substantially equivalent to K960330 (Visualization Technology, Inc., 1996) and 3 other predicates after an 84-day review. Its family tree reaches back 2 generations to 1994. 8 of the 330 devices in its family, counting itself, have a Class I recall. 325 later devices descend from it. It has been recalled 6 times, including a Class I recall.

Decided: Dec 31, 1998
Review: 84 days
Class: Class II
Product code: LLZ
Recalls: 6 (1 Class I)
Predicates: 4

Its longest line of descent runs back 2 generations to K911783 (1994). 4 ancestors in all. 325 later devices descend from it, 5 citing it directly. 8 of the 330 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
1 generation backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
This deviceK983529 Instatrak 3000Visualization Technology, Inc. · 1998
Descendant · cites it directly · 294 of its ownK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled

Showing 5 of 325 descendants. See all descendants

Descendants cleared per year

1999high 35 (2020) · low 0 (2001)2026

Class I recalls in this family

K981998 Pediatric Instatrak Systemdirect predicate · 1998
K960330 Instatrakdirect predicate · 1996
K994270 Instatrak 3000 System with Fluorotrak Module…cites it directly · 2000
K990919 Straight Aspirator, 90 Degree Aspirator,45…cites it directly · 1999

Most influential descendants

Showing 5 of 325 · See all

K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · cites it directly294descendants
K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	1994	—
−1	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
0 (this device)	K983529	Instatrak 3000	Visualization Technology, Inc.	1998	—
+1	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000	Visualization Technology, Inc.	2000	Class I
+1	K053610	Abaris	Traxtal Technologies, Inc.	2006	3
+2	K121498	Percunav	Philips Health Care	2012	—
+3	K132304	Epiq Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2013	36
+4	K160807	EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System…	Philips Ultrasound, Inc.	2016	33

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	1
2000	1	1
2002	1	1
2004	1	0
2006	3	0
2008	2	0
2009	2	0
2010	2	0
2011	2	0
2012	6	0
2013	4	0
2014	12	0
2015	18	0
2016	23	0
2017	34	0
2018	22	0
2019	17	0
2020	35	0
2021	26	0
2022	24	0
2023	19	0
2024	19	0
2025	28	2
2026	23	0

FIG. 1 — Lineage of K983529, 1994–2026Source: 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.

8 devices in this family have a Class I recall. 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

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
*	K960330	Instatrak Summary page 1 …000 Common/Usual Name: Interactive Image Guided Surgical System Classification Name: Computed Tomography X-Ray System 3. PREDICATE DEVICES InstaTrak System, subject of K960330, Pediatric InstaTrak System, subject of K981998, Stealth Station manufactured by Surgical Navigation Technologies, subject of K9…	Visualization Technology, Inc.	1996	Class I
*	K981998	Pediatric Instatrak System Summary page 1 …Surgical System Classification Name: Computed Tomography X-Ray System 3. PREDICATE DEVICES InstaTrak System, subject of K960330, Pediatric InstaTrak System, subject of K981998, Stealth Station manufactured by Surgical Navigation Technologies, subject of K954276 Viewing Wand manufactured by ISG Technolog…	Visualization Technology, Inc.	1998	Class I
*	K954276	Stealthstation Summary page 1 …ICES InstaTrak System, subject of K960330, Pediatric InstaTrak System, subject of K981998, Stealth Station manufactured by Surgical Navigation Technologies, subject of K954276 Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783. 4. DEVICE DESCRIPTION The InstaTrak System is an image…	Surgical Navigation Technologies, Inc.	1996	1
*	K911783	Allegro Viewing Wand Summary page 1 …subject of K981998, Stealth Station manufactured by Surgical Navigation Technologies, subject of K954276 Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783. 4. DEVICE DESCRIPTION The InstaTrak System is an image guidance system indicated for use during sinus, skull base, cranial and…	I.S.G. Technologies, Inc.	1994	—

Also cleared against K960330: 7 other devices →

What descends from it? (325)

See all 325

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000 Class I	Visualization Technology, Inc.	2000	294
K053610	Abaris	Traxtal Technologies, Inc.	2006	278
K133573	Fiagon Navigation System	Fiagon GmbH	2014	28
K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	11
K990919	Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended… Class I	Visualization Technology, Inc.	1999	0

Has anything in its family been recalled? (8 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 22, 2009	Class I	Z-2251-2012	Labeling False and Misleading	GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
Feb 6, 2006	Not classified	Z-0709-06	Other	Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
Jan 26, 2005	Not classified	Z-0704-2007	Other	Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
Dec 13, 2004	Not classified	Z-0689-05	Other	Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Jul 12, 2004	Not classified	Z-0814-05	Other	Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
Jul 12, 2004	Not classified	Z-0815-05	Other	Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

The 5 latest of 6 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 12 Class I recalls
K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight…Visualization Technology, Inc. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
3 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K994270 (Visualization Technology, Inc., 2000) has gone furthest, with 294 descendants of its own.
7 other devices also cite its predicate K960330.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

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/K983529 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983529: Instatrak 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983529

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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