FDA-Device2025-06-25Class II

Ami HTX.

Spectral Instruments Inc
Hazard

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

Sold states
US
Affected count
34
Manufactured in
420 N Bonita Ave, N/A, Tucson, AZ, United States
Products
Ami HTX.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1942-2025

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