Medical Device Manufacturer · US , New York , NY

Konica Minolta, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2014

Total

Cleared

Denied

Konica Minolta, Inc. is a global imaging and technology company with a manufacturing facility in New York, US. The company develops advanced diagnostic and imaging solutions for healthcare and industrial applications.

Konica Minolta has received 25 FDA 510(k) clearances from 25 total submissions, with no denied submissions on record. The company specializes exclusively in Radiology devices, establishing a focused regulatory portfolio. Its FDA 510(k) clearance history spans from 2014 to 2025, with recent clearances demonstrating continued active development and market engagement in advanced imaging technologies.

Recent cleared devices include the SKR 3000, Bone Suppression Software, KONICAMINOLTA DI-X1, Ultrasound System SONIMAGE MX1, and ImagePilot. These products reflect the company's expertise in radiological imaging, software-based diagnostic enhancement, and ultrasound systems for clinical use.

Explore the complete list of device names, product codes, and clearance dates in the database to review Konica Minolta's full regulatory submission history.

510(k) submissions have been managed by Konica Minolta Healthcare Americas, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Konica Minolta, Inc.

25 devices

1-12 of 25