510(k) · Cleared

Cleared

Allegro Viewing Wand

K911783510(k) TraditionalCleared Apr 7, 19941,081-day reviewClass II21 CFR 892.2050

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

I.S.G. Technologies, Inc. · LLZ System, Image Processing, Radiological

Cleared on Apr 7, 1994 after a 1,081-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 of the 553 devices in its family, counting itself, have a Class I recall. 552 later devices descend from it.

Decided: Apr 7, 1994
Review: 1,081 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

552 later devices descend from it, 8 citing it directly. 8 of the 553 devices in this family, counting this one, have a Class I recall.

This deviceK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
Descendant · cites it directly · 327 of its ownK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
Descendant · cites it directly · 325 of its ownK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
Descendant · 2 generations on · 294 of its ownK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
Descendant · cites it directly · 280 of its ownK982994 Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
Descendant · 2 generations on · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled

Showing 5 of 552 descendants. See all descendants

Descendants cleared per year

1996high 50 (2020) · low 1 (2000)2026

Class I recalls in this family

K981998 Pediatric Instatrak Systemcites it directly · 1998
K983529 Instatrak 3000cites it directly · 1998
K982994 Skull Base Instatrak Systemcites it directly · 1998
K990919 Straight Aspirator, 90 Degree Aspirator,45…2 generations on · 1999

Most influential descendants

Showing 5 of 552 · See all

K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · cites it directly327descendants
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · cites it directly325descendants
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations on294descendants
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · cites it directly280descendants
K053610AbarisTraxtal Technologies, Inc. · 2006 · 2 generations on278descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	1994	—
+1	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
+1	K983529	Instatrak 3000	Visualization Technology, Inc.	1998	Class I
+2	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000	Visualization Technology, Inc.	2000	Class I
+1	K982994	Skull Base Instatrak System	Visualization Technology, Inc.	1998	Class I
+2	K053610	Abaris	Traxtal Technologies, Inc.	2006	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	5	0
1997	5	0
1998	10	3
1999	12	1
2000	1	1
2001	1	0
2002	1	1
2003	3	0
2004	4	0
2005	4	0
2006	4	0
2007	1	0
2008	6	0
2009	4	0
2010	4	0
2011	5	0
2012	12	0
2013	8	0
2014	16	0
2015	25	0
2016	28	0
2017	47	0
2018	29	0
2019	27	0
2020	50	0
2021	36	0
2022	38	0
2023	43	0
2024	34	0
2025	49	2
2026	40	0

FIG. 1 — Lineage of K911783, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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?

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

What descends from it? (552)

See all 552

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

Number	Device	Applicant	Decided	Descendants
K981998	Pediatric Instatrak System Class I	Visualization Technology, Inc.	1998	327
K983529	Instatrak 3000 Class I	Visualization Technology, Inc.	1998	325
K982994	Skull Base Instatrak System Class I	Visualization Technology, Inc.	1998	280
K961168	Viewpoint	Philips Medical Systems (Cleveland), Inc.	1996	161
K961844	Operating Arm System (Oas) [with CT and MR Images]	Radionics Software Applications, Inc.	1996	158
K960714	Isg Viewing Wand	I.S.G. Technologies, Inc.	1996	71
K955397	Mayfield-Acciss Workstation	Nomos Corp.	1996	15
K961834	Philips Easyguide Neuro	Philips Medical Systems, Inc.	1996	0

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

No FDA recall names this device.

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 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight…Visualization Technology, Inc. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations on · ◆ in the 2000 descendants bar of FIG. 12 Class I recalls
K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · 3 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

Of its descendants, K981998 (Visualization Technology, Inc., 1998) has gone furthest, with 327 descendants of its own.

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	—

https://510kreport.com/device/K911783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911783: Allegro Viewing Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911783

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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