510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092713Substantially Equivalent

Spectre Wireless Encrypted Footswitch and Hand Switch System

Transamerican Medical Imaging, Lindon UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092713 is the FDA 510(k) clearance record for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM, a class II device, cleared for Transamerican Medical Imaging on under FDA product code IZL (System, X-Ray, Mobile). FDA records list one 510(k) clearance for Transamerican Medical Imaging. As of , FDA records show one recall naming K092713.

Clearance record

Decision date
Received
(316 days to decision)
Product code
IZL System, X-Ray, Mobile
Regulation
21 CFR 892.1720
Device class
Class II
Review panel
Radiology
Applicant
Transamerican Medical Imaging 965 W. 325 N., Lindon UT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IZL

Trailing 12 months
6 clearances under product code IZL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IZL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20261
July 20260
August 20261
September 20260
October 20260