510(k) · Cleared

Cleared

SNN Fluoro Navigation System

K993673510(k) TraditionalCleared Dec 21, 199950-day reviewClass II21 CFR 882.4560

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. · HAW Neurological Stereotaxic Instrument

Cleared on Dec 21, 1999 as substantially equivalent to K982570 (I.S.G. Technologies, Inc., 1999) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1999.

Decided: Dec 21, 1999
Review: 50 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K982570 (1999). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK982570 SNN ScoutI.S.G. Technologies, Inc. · 1999
This deviceK993673 SNN Fluoro Navigation SystemI.S.G. Technologies, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982570	SNN Scout	I.S.G. Technologies, Inc.	1999	—
0 (this device)	K993673	SNN Fluoro Navigation System	I.S.G. Technologies, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K993673, 1999–1999Source: 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 HAW? 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 HAW device

#1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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? (2)

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
*	K982570	SNN Scout Summary page 1 …V 187 Dolores McGirr, Regulatory Scientist (905) 672-2100 October 26, 1999 SNN Fluoro Navigation System Image-Guided Surgical System. Stereotaxic Device. SNN System K982570; the Stealth Station with FluoroNav Module by Surgical Navigation Technologies K990214. The SNN Fluoro Navigation System is a mo…	I.S.G. Technologies, Inc.	1999	—
*	K990214	Fluoronav Module for the Stealthstation System Summary page 1 …ro Navigation System Image-Guided Surgical System. Stereotaxic Device. SNN System K982570; the Stealth Station with FluoroNav Module by Surgical Navigation Technologies K990214. The SNN Fluoro Navigation System is a module of the SNN System to provide image-guided surgery based on an intra- operative flu…	Surgical Navigation Technologies, Inc.	1999	29

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?

1 of the 2 ancestors has a recall of any class.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007high 238 (2014) · low 66 (2011)2026

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

Recalls per year · HAW

2in 2025

2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, 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	15	107	2	49
2008	12	112	10	53
2009	8	221	6	96
2010	6	138	28	299
2011	4	66	5	1,725
2012	8	178	4	986
2013	3	172	6 (1)	1,290
2014	5	238	5	1,606
2015	10	232	3	1,767
2016	9	175	5	1,828
2017	7	226	2	3,505
2018	6	112	2 (2)	4,439
2019	10	147	4 (1)	6,062
2020	5	88	1	3,480
2021	9	168	4 (2)	2,827
2022	7	128	1	1,929
2023	14	142	4 (1)	2,510
2024	7	107	2 (2)	3,755
2025	9	163	2	3,425
2026	5	162	6	—

What is it indicated for?

The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob’s disease if adequate sterilization of the instruments cannot be assured.

The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.

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/K993673 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993673: SNN Fluoro Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993673

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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