Device Desk

Private service · Not FDA

FDA device establishment · Rochester, 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-1317307As of September 30, 2026

Carestream Health, Inc

Registration 1317307FEI 1317307Rochester, NY

Owner/operator: Carestream Health, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel 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
27
Added, last 12 months
5

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 27

CodeDeviceClassRegulationPremarket
IXACR Cassettes for Vita SystemsCassette, Radiographic FilmClass 221 CFR 892.1850K945039
IXADIRECTVIEW CR CASSETTESCassette, Radiographic FilmClass 221 CFR 892.1850K040378
MUECARESTREAM CR Mammography Cassette with EHR-M3 ScreenFull Field Digital, System, X-Ray, MammographicClass 221 CFR 892.1715P080018
MQBCARESTREAM DRX-EVOLUTION PLUSSolid State X-Ray Imager (Flat Panel/Digital Imager)Added Mar 13, 2026Class 221 CFR 892.1680K250954
MQBDRX-LC DetectorSolid State X-Ray Imager (Flat Panel/Digital Imager)Added Mar 13, 2026Class 221 CFR 892.1680K253185
MQBFocus 43C DetectorSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K200622
MQBDIRECTVIEW CR LONG-LENGTH IMAGING SYSTEMSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K021829
MQBFocus HD 35 DetectorSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K213646
MQBCARESTREAM DRX-1 SystemSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K090318
MQBLux HD 35 Detector (Lux HD 35)Solid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K243556
MQBDRX Core 3543 Detector DRX Core 3543C DetectorSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K150766
MQBDRX Plus 2530C DetectorSolid State X-Ray Imager (Flat Panel/Digital Imager)Class 221 CFR 892.1680K130464

and 15 more on your full dossier

What changed

  • Mar 13, 2026Listing added: MQB — CARESTREAM DRX-EVOLUTION PLUS (K250954)
  • Mar 13, 2026Listing added: MQB — DRX-LC Detector (K253185)
  • Mar 13, 2026Listing added: MQB — Lux HD 2530 Detector (Lux HD 2530) (K252911)
  • Mar 13, 2026Listing added: IZL — DRX-LC Detector (K253185)
  • Mar 13, 2026Listing added: KPR — CARESTREAM DRX-EVOLUTION PLUS (K250954)
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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