Medical Device Manufacturer · US , New York , NY

Radformation, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2017

Total

Cleared

Denied

Radformation, Inc. develops intelligent automation software for cancer care and radiation oncology. The company specializes in treatment planning, quality assurance, and clinical workflow optimization with a manufacturing facility in New York, US.

Radformation has received 14 FDA 510(k) clearances from 14 total submissions, all in Radiology devices. The company's regulatory track record spans from 2017 to 2026, with its most recent clearance in 2026 demonstrating continued active development and market presence.

The company's cleared portfolio includes automated contouring, treatment planning, plan evaluation, independent dose calculation, and treatment monitoring software. Products address key workflow stages from patient imaging through treatment delivery and billing quality assurance.

Explore the complete list of device names, product codes, and individual clearance dates in the database.

FDA 510(k) Regulatory Record - Radformation, Inc.

14 devices

1-12 of 14