510(k) · Cleared

Recalled · Class II · 2013

Spectre Wireless Encrypted Footswitch and Hand Switch System

K092713510(k) TraditionalCleared Jul 16, 2010316-day reviewClass II21 CFR 892.1720Recalls 1

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

Transamerican Medical Imaging · IZL System, X-Ray, Mobile

Cleared on Jul 16, 2010 as substantially equivalent to K973482 (Philips Medical Systems North America, Inc., 1997) and 6 other predicates after a 316-day review. Its family tree reaches back 6 generations to 1989. 2 of the 21 devices in its family, counting itself, have a Class I recall. It has been recalled once.

Decided: Jul 16, 2010
Review: 316 days
Class: Class II
Product code: IZL
Recalls: 1
Predicates: 7

Its longest line of descent runs back 6 generations to K890348 (1989). 20 ancestors in all. No later device cites it as a predicate yet. 2 of the 21 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
4 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
3 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
2 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
1 generation backK041949 Allura Xper FD10Philips Medical Systems North America Co. · 2004 · Recalled
This deviceK092713 Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010

Class I recalls in this family

K024012 Oec 9800 E/CV+ Digital Mobile Imaging Systemdirect predicate · 2003
K021049 Oec 9800 Plus Digital Mobile Imaging System3 generations back · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K890348	LC, Cardiac Positioner #B5078A	General Electric Co.	1989	5
−5	K993037	LCV+ Version 2	Ge Medical Systems, Inc.	2000	6
−4	K020055	Philips Integris Allura 9 with FD Option	Philips Medical Systems	2002	2
−3	K022899	Philips Integris Allura Flat Detector Release 1.0	Philips Medical Systems North America Co.	2002	8
−2	K031333	Philips Integris Allura Flat Detector Release 1.2	Philips Medical Systems North America, Inc.	2003	25
−1	K041949	Allura Xper FD10	Philips Medical Systems North America Co.	2004	48
0 (this device)	K092713	Spectre Wireless Encrypted Footswitch and Hand Switch System	Transamerican Medical Imaging	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1993	1	0
1995	1	0
1997	2	0
1998	1	0
1999	1	0
2001	1	0
2002	1	1
2003	2	1
2004	1	0
2008	1	0

FIG. 1 — Lineage of K092713, 1989–2010Source: 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.

2 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 IZL device

#1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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? (7)

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
*	K973482	Philips Integris V5000 and BV5000 Summary page 1 …on-image-intensified Fluoroscopic X-ray System Ill. Predicate Devices: Philips Medical Systems Standard Footswitch-Accessory for: * V Series Angiographic system (K973482) * H Series Cardiographic System (K97 1365) * FD Series Cath/Angio System (K04 1949) • Mobile C-arm System (K01076…	Philips Medical Systems North America, Inc.	1997	4
*	K971365	Philips Integris H5000 Summary page 1 …Ill. Predicate Devices: Philips Medical Systems Standard Footswitch-Accessory for: * V Series Angiographic system (K973482) * H Series Cardiographic System (K97 1365) * FD Series Cath/Angio System (K04 1949) • Mobile C-arm System (K010762) * R&F System (K032046) GEIOEC Medical S…	Philips Medical Systems North America, Inc.	1997	17
*	K041949	Allura Xper FD10 Summary page 1 …tems Standard Footswitch-Accessory for: * V Series Angiographic system (K973482) * H Series Cardiographic System (K97 1365) * FD Series Cath/Angio System (K04 1949) • Mobile C-arm System (K010762) * R&F System (K032046) GEIOEC Medical Systems Standard Footswitch-Accessory for:…	Philips Medical Systems North America Co.	2004	48
*	K010762	Philips BV Libra Summary page 1 …: * V Series Angiographic system (K973482) * H Series Cardiographic System (K97 1365) * FD Series Cath/Angio System (K04 1949) • Mobile C-arm System (K010762) * R&F System (K032046) GEIOEC Medical Systems Standard Footswitch-Accessory for: * OIEC 9800 Mobile C-Arm System (…	Philips Medical Systems, Inc.	2001	1
*	K032046	Phillips Omnidiagnost Eleva Summary page 1 …ic system (K973482) * H Series Cardiographic System (K97 1365) * FD Series Cath/Angio System (K04 1949) • Mobile C-arm System (K010762) * R&F System (K032046) GEIOEC Medical Systems Standard Footswitch-Accessory for: * OIEC 9800 Mobile C-Arm System (K0240 12) * OEC 9900…	Philips Medical Systems, Inc.	2003	8
*	K024012	Oec 9800 E/CV+ Digital Mobile Imaging System Summary page 1 …949) • Mobile C-arm System (K010762) * R&F System (K032046) GEIOEC Medical Systems Standard Footswitch-Accessory for: * OIEC 9800 Mobile C-Arm System (K0240 12) * OEC 9900 Mobile C-Arm System CR073543) Sect STMI 510K< Sub V01 132009 A CANYON RIDGE COMPANY WWraniisame rica n…	Ge Oec Medical Systems	2003	Class I
*	K073543	Oec 9900 Elite Summary page 1 …F System (K032046) GEIOEC Medical Systems Standard Footswitch-Accessory for: * OIEC 9800 Mobile C-Arm System (K0240 12) * OEC 9900 Mobile C-Arm System CR073543) Sect STMI 510K< Sub V01 132009 A CANYON RIDGE COMPANY WWraniisame rica nm edilea. co m IV. Product Descri…	Ge Oec Medical Systems	2008	5
†	K062074	Iridex Wireless Footswitch	Iridex Corp	2006	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 22, 2013	Class II	Z-0532-2014	Component design/selection	TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing…

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.

K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 3 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
17 of the 20 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All IZL devices

IZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · IZL

11in 2025

2007high 16 (2022) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZL

153in 2025

2007high 159 (2024) · low 30 (2007)2026

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

Recalls per year · IZL

47in 2025

2007high 47 (2025) · low 0 (2008)2026

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

Adverse event reports per year · IZL

27in 2025

2007high 118 (2011) · low 16 (2007)2025

MAUDE reports naming product code IZL, 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	3	30	7	16
2008	4	49	0	27
2009	3	125	0	35
2010	3	65	4	75
2011	6	66	6	118
2012	3	83	5	24
2013	0	—	10	17
2014	7	104	4	51
2015	4	88	4	30
2016	6	47	0	33
2017	7	45	0	35
2018	8	47	0	27
2019	9	33	2	40
2020	9	43	1	48
2021	13	48	0	47
2022	16	89	1	32
2023	3	55	6	77
2024	9	159	5	39
2025	11	153	47	27
2026	6	157	5	—

What is it indicated for?

The Spectre System is intended for use with compatible diagnostic x-ray systems in hospitals or outpatient facilities. The Spectre System is indicated for use as an accessory to provide input control to compatible x-ray systems. This accessory includes a wireless footswitch, a wireless hand switch, and a receiver. It is cleared for use for the particular indications of the x-ray system to which it is attached.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092713 · printed Nov 5, 2026

Cite this page

510(k) Report. “K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092713

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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