Device Desk

Private service · Not FDA

FDA device establishment · New York, NY

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3013410552As of September 30, 2026

RADFORMATION, INC.

Registration 3013410552FEI 3013410552New York, NY

Owner/operator: Radformation, Inc.

  • Manufacture Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
18
Added, last 12 months
9

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 18

CodeDeviceClassRegulationPremarket
IYEClearCheckAccelerator, Linear, MedicalClass 221 CFR 892.5050K220583
IYEClearCheck (RADCC V2.7)Accelerator, Linear, MedicalAdded Apr 27, 2026Class 221 CFR 892.5050K253962
IYEChartCheckAccelerator, Linear, MedicalClass 221 CFR 892.5050K201119
IYEEZFluence RADEZ V2Accelerator, Linear, MedicalAdded Sep 10, 2026Class 221 CFR 892.5050K261718
IYEChartCheck (RADCH V1.6)Accelerator, Linear, MedicalAdded Mar 9, 2026Class 221 CFR 892.5050K252988
IYEEZFluenceAccelerator, Linear, MedicalClass 221 CFR 892.5050K171352
QIHAutoContour (Model RADAC V4)Automated Radiological Image Processing SoftwareClass 221 CFR 892.2050K242729
QKBAutoContour (Model RADAC V4)Radiological Image Processing Software For Radiation TherapyClass 221 CFR 892.2050K242729
QKBAutoContourRadiological Image Processing Software For Radiation TherapyAdded Aug 18, 2026Class 221 CFR 892.2050K262452
QKBClearCheck (RADCC V2.7)Radiological Image Processing Software For Radiation TherapyAdded Apr 27, 2026Class 221 CFR 892.2050K253962
QKBAutoContourRadiological Image Processing Software For Radiation TherapyClass 221 CFR 892.2050K230685
QKBAutoContour (Model RADAC V5)Radiological Image Processing Software For Radiation TherapyAdded Mar 23, 2026Class 221 CFR 892.2050K260509

and 6 more on your full dossier

What changed

  • Apr 27, 2026Listing added: IYE — ClearCheck (RADCC V2.7) (K253962)
  • Sep 10, 2026Listing added: IYE — EZFluence RADEZ V2 (K261718)
  • Mar 9, 2026Listing added: IYE — ChartCheck (RADCH V1.6) (K252988)
  • Aug 18, 2026Listing added: QKB — AutoContour (K262452)
  • Apr 27, 2026Listing added: QKB — ClearCheck (RADCC V2.7) (K253962)
  • Mar 23, 2026Listing added: QKB — AutoContour (Model RADAC V5) (K260509)
  • Sep 10, 2026Listing added: MUJ — EZFluence RADEZ V2 (K261718)
  • Mar 9, 2026Listing added: MUJ — ClearCalc RADCA V2.6 (K252863)
  • Apr 27, 2026Listing added: MUJ — ClearCheck (RADCC V2.7) (K253962)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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