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

Radformation, Inc. (New York, New York): 3 new FDA device listings, incl. radiological image processing software for radiation therapy. Its amount of 3 is above the median of 1 (77th percentile). Dated 56 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 55 related NY DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentRadformation, Inc.
RoleManufacturer
Establishment typesManufacture Medical Device
LocationNew York, NY, US
New listings3
DevicesRadiological Image Processing Software For Radiation Therapy; System, Planning, Radiation Therapy Treatment; Accelerator, Linear, Medical
Product codesQKB, MUJ, IYE
Device classesClass II
Medical specialtiesRadiology
Brand namesAutoContour; 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 listing2026-08-18
Latest new listing2026-09-10
FDA registration number3013410552
Registration expires2027-12-31
amount percentile77th of 2,570 (median 1, 3.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-09-10
  • Data refreshed: 2026-10-28
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT

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Peer benchmark and outreach value: Radformation, Inc. and 56 New York peers

  • New York DeviceEstablishmentPulse records like this one: 56
  • Radformation, Inc.'s amount: 77th percentile of 2,570 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every New York peer: $11,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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85 / 100 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.

What is the DeviceEstablishmentPulse record for Radformation, Inc. in New York, New York?

Radformation, Inc. (New York, NY), a manufacturer, added 3 FDA device listings between 2026-08-18 and 2026-09-10.

How does Radformation, Inc. compare to other New York DeviceEstablishmentPulse records?

Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 56 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.

Radformation, Inc. vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Radformation, Inc.New York, NY377th2026-09-10
Beacon Biosignals, Inc.Boston, MA377th2026-10-16
Endovascular Engineering, Inc.Menlo Park, CA377th2026-10-14
INNO Holdings Inc.Millcreek, UT377th2026-10-05

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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.

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