Company profile

Brainomix Limited

Brainomix Limited has 8 AI-enabled medical devices on the FDA list. The first decision was on February 23, 2023 and the most recent on June 12, 2026 (Brainomix 360 Hyperdensity). Its most common review panel is Radiology (8 devices).

8AI devices

2023First decision

2026Latest decision

1Specialties

Per year

202320252026

Brainomix Limited AI devices per year: 2023 4, 2025 3, 2026 1

By specialty

Radiology8

Related guides

Top radiology devices

Timeline

June 12, 2026 · 510(k) K260406Brainomix 360 Hyperdensity · Radiology · QIH
August 26, 2025 · 510(k) K251983Brainomix 360 Triage Stroke · Radiology · QAS
February 14, 2025 · 510(k) K243294Brainomix 360 e-ASPECTS · Radiology · POK
January 6, 2025 · 510(k) K242123Brainomix 360 e-CTA · Radiology · LLZ
November 21, 2023 · 510(k) K232496Brainomix 360 Triage Stroke · Radiology · QAS
September 28, 2023 · 510(k) K231837Brainomix 360 Triage LVO · Radiology · QAS
July 27, 2023 · 510(k) K231195Brainomix 360 Triage ICH · Radiology · QAS
February 23, 2023 · 510(k) K221564Brainomix 360 e-ASPECTS · Radiology · POK