Device Desk

Private service · Not FDA

FDA device establishment · Somerville, MA

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-3018733944As of September 30, 2026

DEEPHEALTH

Registration 3018733944FEI 3018733944Somerville, MA

Owner/operator: DeepHealth

  • 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
24
Added, last 12 months
19

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 24

CodeDeviceClassRegulationPremarket
QIHMammo DensityAutomated Radiological Image Processing SoftwareAdded Nov 18, 2025Class 221 CFR 892.2050K243705
QIHBreast Arterial Calcification (BAC)Automated Radiological Image Processing SoftwareAdded Jun 9, 2026Class 221 CFR 892.2050K254131
QIHBrain WMHAutomated Radiological Image Processing SoftwareAdded Jul 22, 2026Class 221 CFR 892.2050K251527
QIHSaige-DensityAutomated Radiological Image Processing SoftwareClass 221 CFR 892.2050K222275
QDQDeepHealth Prostate AIRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerAdded Jul 22, 2026Class 221 CFR 892.2090K253682
QDQSaige-DxRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerClass 221 CFR 892.2090K241747
QDQSaige-DxRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerClass 221 CFR 892.2090K220105
QDQProFound Pro; Mammo DxRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerAdded Jun 29, 2026Class 221 CFR 892.2090K253825
QDQProFound ProRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerAdded Nov 18, 2025Class 221 CFR 892.2090K251873
QDQSaige-DxRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerAdded Nov 18, 2025Class 221 CFR 892.2090K243688
QFMSaige-QRadiological Computer-Assisted Prioritization Software For LesionsClass 221 CFR 892.2080K203517
LLZQuantib ProstateSystem, Image Processing, RadiologicalAdded Jul 22, 2026Class 221 CFR 892.2050K202501

and 12 more on your full dossier

What changed

  • Nov 18, 2025Listing added: QIH — Mammo Density (K243705)
  • Jun 9, 2026Listing added: QIH — Breast Arterial Calcification (BAC) (K254131)
  • Jul 22, 2026Listing added: QIH — Brain WMH (K251527)
  • Jul 22, 2026Listing added: QDQ — DeepHealth Prostate AI (K253682)
  • Jun 29, 2026Listing added: QDQ — ProFound Pro; Mammo Dx (K253825)
  • Nov 18, 2025Listing added: QDQ — ProFound Pro (K251873)
  • Nov 18, 2025Listing added: QDQ — Saige-Dx (K243688)
  • Jul 22, 2026Listing added: LLZ — Quantib Prostate (K202501)
  • Jul 22, 2026Listing added: LLZ — Quantib Prostate (K221106)
  • Jul 22, 2026Listing added: LLZ — Quantib Brain 1.2 (K163013)
  • Nov 18, 2025Listing added: LLZ — TechLive (K243703)
  • Sep 17, 2026Listing added: LLZ — DeepHealth Viewer (K241223)
  • Jul 22, 2026Listing added: LLZ — Quantib ND (K213737)
  • Jul 22, 2026Listing added: LLZ — Quantib Prostate (K230772)
  • Nov 18, 2025Listing added: LLZ — Brain Age (K192051)
  • Jul 22, 2026Listing added: LLZ — Quantib ND (K182564)
  • Jul 22, 2026Listing added: LLZ — Quantib AI Node (K200899)
  • Sep 17, 2026Listing added: LLZ — PracticeBuilder 1-2-3 (K120995)
  • Jul 22, 2026Listing added: LLZ — Quantib Brain (K173939)
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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