SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM— 510(k) K092713

Substantially Equivalent

Transamerican Medical Imaging

FDA 510(k) clearance K092713 for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM, Substantially Equivalent on 2010-07-16. Applicant: Transamerican Medical Imaging.

Clearance details

Applicant: Transamerican Medical Imaging
Product code: Code IZL
Advisory panel: Radiology
Date received: 2009-09-03
Decision date: 2010-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lindon, UT, US

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Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.