# Radformation, Inc. (manufacturer, New York, NY): 3 new FDA device listings, incl. radiological image processing software for radiation therapy

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Radformation, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | New York, NY, US |
| New listings | 3 |
| Devices | Radiological Image Processing Software For Radiation Therapy; System, Planning, Radiation Therapy Treatment; Accelerator, Linear, Medical |
| Product codes | QKB, MUJ, IYE |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | AutoContour; AutoContour Model RADAC V6; AutoContour Version 2.8; AutoContour Zero-Click; EZFluence Version 2.6; OptiPlan; EZFluence RADEZ V2; EZFluence Version 2.7 |
| First new listing | 2026-08-18 |
| Latest new listing | 2026-09-10 |
| FDA registration number | 3013410552 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.