Medical Device Manufacturer · FR , Lyon

Diagnoly - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024

Total

Cleared

Denied

Diagnoly has 2 FDA 510(k) cleared medical devices. Based in Lyon, FR.

Latest FDA clearance: Sep 2025. Active since 2024. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Diagnoly Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

FDA 510(k) Regulatory Record - Diagnoly

2 devices

1-2 of 2

Regulatory Intelligence

PCCP authorized FDA software change control pathway

Regulatory consultant 510(k) submission support ecosystem

Mcra, LLC

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026

Diagnoly - FDA 510(k) Cleared Devices

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