Introduction
The MOBILETT Impact is a mobile X-ray system designed to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image.
Indications for Use
The device is intended for prescription use and is not intended for mammography examinations.
Device Classification
The MOBILETT Impact is classified as a Class II device under 21 CFR 892.1720, with a product code of IZL.
Legally Marketed Predicate Devices
The device is substantially equivalent to legally marketed predicate devices, including the SM-V SEDECAL SA and the MULTIX Impact.
Manual:
Download: MOBILETT Impact Mobile X-ray System User Manual
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