# K092713: Spectre Wireless Encrypted Footswitch and Hand Switch System

- Pathway: 510(k) (Traditional)
- Applicant: Transamerican Medical Imaging
- Decided: Jul 16, 2010 after 316 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K890348 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973482: Philips Integris V5000 and BV5000, Philips Medical Systems North America, Inc. (1997) Summary page 1.
- K971365: Philips Integris H5000, Philips Medical Systems North America, Inc. (1997) Summary page 1.
- K041949: Allura Xper FD10, Philips Medical Systems North America Co. (2004) Summary page 1.
- K010762: Philips BV Libra, Philips Medical Systems, Inc. (2001) Summary page 1.
- K032046: Phillips Omnidiagnost Eleva, Philips Medical Systems, Inc. (2003) Summary page 1.
- K024012: Oec 9800 E/CV+ Digital Mobile Imaging System, Ge Oec Medical Systems (2003) Summary page 1.
- K073543: Oec 9900 Elite, Ge Oec Medical Systems (2008) Summary page 1.

## Recalls of this device
- Aug 22, 2013 · Class II · Z-0532-2014: 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 t

## Indications for use
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.

Source page: https://510kreport.com/device/K092713
Methodology: https://510kreport.com/methodology