Radiology · 510(k) · 2026
Saige-Dx
DeepHealth, Inc.. Cleared by FDA on 15 June 2026 under submission K253825, product code QDQ (radiological computer assisted detection/diagnosis software for lesions suspicious for cancer). What FDA's record says, in FDA's words.
Device record · K253825
- Device. Saige-DxDEVICE
- Company. DeepHealth, Inc.COMPANY
- Decision. 15 June 2026, 510(k), substantially equivalent (traditional review); received 1 December 2025DECISION
- Panel. RadiologyPANEL
- Product code. QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerCODE
- Regulation. 21 CFR 892.2090, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.Please provide the device trade name(s). Please provide your Indications for Use below. Please select the types of uses (select one or both, as applicable).Prescription Use (21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) K253825? ? Saige-Dx? Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence or absence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.? 212 Elm St Somerville, MA 02144 www.deephealth.com 510(k) Summary - Saige-Dx - DeepHealth, Inc 1 K253825 510(k) Summary DeepHealth, Inc Saige-Dx In accordance with 21 CFR 807.92 the following summary of information is provided, on this date, June 12, 2026: 1. 510(k) SUBMITTER DeepHealth,Inc Attn: B. Nathan Hunt 212 Elm St. Somerville, MA 02144 Tel: 443-506-8911 Contact Person: Spence Hartwell Principal, Regulatory Affairs DeepHealth, […]
The product code's definition, from FDA's classification record. A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QDQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QDQ, in Radiology, from DeepHealth, Inc., or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.