Company profile

ABBOTT MEDICAL

ABBOTT MEDICAL has 3 AI-enabled medical devices on the FDA list. The first decision was on June 8, 2021 and the most recent on April 24, 2026 (OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)). Its most common review panel is Radiology (2 devices).

3AI devices
2021First decision
2026Latest decision
2Specialties

Per year

2021: 12025: 12026: 1
202120252026
ABBOTT MEDICAL AI devices per year: 2021 1, 2025 1, 2026 1

By specialty

  • Radiology2
  • Cardiovascular1

Related guides

Top radiology devices

Timeline

  1. OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) · Radiology · NQQ
  2. Assert-IQ (DM5100) · Cardiovascular · MXD
  3. OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System · Radiology · NQQ