Abbott Medical

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Abbott Medical on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-04-24	K253459	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	ABBOTT MEDICAL	Radiology
2025-12-18	K253516	Assert-IQ (DM5100)	Abbott Medical	Cardiovascular
2021-06-08	K210458	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	Abbott Medical	Radiology

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